NYC CHAIN Report (Update Report # 19) Trends in Current Use of HIV Antiretroviral Medication in Peter Messeri

Transcription

1 NYC CHAIN Report (Update Report # 19) Trends in Current Use of HIV Antiretroviral Medication in 1998 Peter Messeri Columbia University Mailman School of Public Health In collaboration with Medical and Health Research Association of New York, the NYC Department of Health and Mental Hygiene, the Westchester Department of Health, and the NY Health & Human Services HIV Planning Council HRSA Contract BRH Final submitted May 3, The Trustees of Columbia University C.H.A.I.N. Report

2 C P H P A P I P N P Community Health Advisory and Information Network Update Report #19 May 3, 1999 Trends in Current Use of HIV Antiretroviral Therapy Prepared by Peter Messeri Joseph L. Mailman School of Public Health Columbia University This research was supported by grant number BRH from the US Health Resources and Services Administration (HRSA). This study was supported by the HIV Health and Human Services Planning Council of New York under a Title I grant of the Ryan White Comprehensive AIDS Resource Emergency Act of 1990 through the New York City Department of Health. It was conducted under the auspices of the Medical and Health Research Association of New York City, Inc. Its contents are solely the responsibility of the Joseph L. Mailman School of Public Health of Columbia University and do not necessarily represent the views of the funders.

3 ACKNOWLEDGMENTS A Technical Review Team (TRT) provides oversight for the CHAIN Project. In addition to Peter Messeri, PhD and Angela Aidala, PhD, both of Columbia s Mailman School of Public Health, TRT members include Dorothy Jones Jessop, PhD (Chair), MHRA; Mary Ann Castle, PhD, Office of the Mayor/AIDS Policy Coordination; Les Hayden, HIV Care Services/MHRA; Joanne Hilger, NYCDOH; Jean Kalinowski, HIV Planning Council; Arturo Llerandi-Phipps; Katherine A. Nelson, PhD, MHRA; and Ravi Patur, HIV Care Services/MHRA. TABLE OF CONTENTS Introduction 1 The CHAIN Survey & Data 3 Findings 10 Conclusion 36 APPENDIX: Logistic Regression 39

4 I. Introduction Earlier CHAIN reports (Update #1 and #12) have documented the rapid rise in the use of combination antiretroviral therapies during 1996 and 1997 among CHAIN participants--a representative cohort of HIV-infected New York City residents. Among CHAIN participants who completed fourth round interviews that were conducted during the first 10 months of 1997 (N=420), 61 percent were taking a combination therapy at the time of the interview and 41 percent were taking a triple combination that included a protease inhibitor. The most salient factors associated with use of antiretroviral therapy during 1997 were supressed CD4 T-cell counts, higher educational attainment, the number of family members and friends aware of a participant s HIV status, continuity of medical care, and access to medical care that was comprehensive, coordinated and provided 24-hour coverage. This report extends the findings of the earlier reports to the experiences reported during the fifth round of interviews. A major change from previous rounds of interviews is the addition of 253 new study participants who were recruited to supplement the continuing cohort. The refresher cohort presents the experiences of a number of individuals who became aware of their HIV infection after the introduction of protease inhibitors, during the Winter of 1995/1996. Major topics covered in this report include: Trends in current use of antiretroviral therapies run through 1998; Influences of study participant and provider characteristics on use of combination therapy; Separate analyses of the use of combination therapies among individuals with low mental health functioning and current users of alcohol and other drugs; The impact of combination therapy on use of medical care services and case management services. 1

5 A companion Update Report #20 examines experiences with adherence to complex antiretroviral therapies. Key Findings The fifth round of interviews, largely completed during 1998, shows that current use of combination therapies have achieved a sustained plateau of high use. Among CHAIN participants interviewed during 1998 almost half reported taking a combination that conformed to the highly active triple-drug therapies that include a protease inhibitor or to a much lesser extent a non-nucleoside reverse transcriptase inhibitor (NNRTI). Almost 3/4 of the cohort were currently taking some type of combination therapy. As the medications have become widely available in New York City, there are fewer systematic relationships between participant characteristics and current use of combination therapy. Instead, the most important factors influencing an individual s use of combination therapy involve a relative, small group of the most vulnerable individual s. Living in or being at high risk for unstable housing situations and having lower mental health functioning are the two most important participant characteristics limiting use of combination therapy. Among the participants with the lowest levels of use of the more potent triple combination therapies were the very small number of individuals responsible for caring for three or more dependent children. Although recent substance use generally had only modest effect on lowering use of combination therapies, the small number of regular crack/cocaine users had substantially lower use of these therapies. Access to combination therapy is relatively uniform across different medical care settings. 2

6 Higher use of combination therapy is reported by indiviuals who receive medical care from a provider whom they characterize as providing coordinated, compulsive, & accessible care. Use of combination therapy is relatively uniform across major forms of insurance coverage, be it private, Medicaid or other public programs. The influences that predict use of combination therapy for the general CHAIN cohort operate in a similar fashion for recent alcohol and other drug users and people with low mental health functioning. Use of combination therapy is associated with a drop in hospital stays and only a modest increase in outpatient visits. It is also associated with an increase in case management visits. II. Methodology -- The CHAIN Survey and Data The Mailman School of Public Health is responsible for conducting the CHAIN Project surveys and reporting on findings from the survey data in collaboration with the New York City Department of Health and with the Medical and Health Research Association of New York City, Inc. (MHRA). The purpose of the surveys is to provide longitudinal information on study participants needs for health and human services, their use of health care and social services, their satisfaction with services, and the impact of these services on changes in their physical, mental, and social wellbeing. This information is prepared specifically for the NYC HIV Health and Human Services Planning Council to assess the full spectrum of services for HIV infected persons in NYC. The study is conducted under a subcontract from MHRA to Columbia University with the authorization of the NYC Department of Health and the HIV Planning Council. 3

7 Chain Sample Design and Participant Recruitment At its inception in 1994, the CHAIN Project pursued a recruitment procedure designed to yield a broadly representative sample of people living with HIV in New York City. Study recruitment was conducted collaboratively with 43 randomly selected agencies, stratified to represent roughly equal numbers of medical care and social service sites as well as sites that were and were not recipients of Ryan White Title I grants. At 30 sites, staff contacted a random sample of clients. The names of clients who indicated an interest in participating were turned over to CHAIN staff for interviews. An open enrollment procedure was implemented at the remaining 13 agencies. All eligible clients present on a small number of recruitment days were invited by agency providers and CHAIN staff to participate in the CHAIN study. Interviews were then scheduled with interested clients. A total of 648 individuals recruited from participating agencies completed baseline interviews that were conducted between October 1994 and September The agency-based sample was supplemented with 52 interviews conducted with HIV+ individuals with little or no connection to medical and social services. These individuals were contacted at outreach sites and through nominations from CHAIN participants. More detailed information on sampling strategy and recruitment may be obtained upon request from MHRA (CHAIN Technical Report #1). Table 1. Status of Original CHAIN Cohort from , n=700 Participant status as of 1998 n % Interviewed % Deceased % Moved out of New York City 44 6% Institutionally unavailable (e.g., jail) 12 2% Mentally or physically unable to participate 6 1% Refused 27 4% Unable to locate 67 10% 4

8 The research team has completed four rounds of interviews beyond the original study, with an interval of approximately six to nine months between interviews. 1 The team uses multiple strategies to recontact or confirm the status of individuals. On occasion an individual who has been lost at an one round is recontacted and interviewed for later rounds. The rigorous follow-up activities have ensured that well over 80 percent of participants interviewed at one round of interviews are re-interviewed at the next round. Nonetheless, after five rounds of interviews over a four-year period, there has been a cumulative loss of 45% of the original cohort. As Table 1 illustrates, half of the cohort attrition has been an inevitable consequence of the high rate of mortality experienced by HIV infected individuals (23%). The overwhelming majority of the cohort (80%) who are physically able and still residing in New York City have continued to participate in the study. For the 1998 contract year, the HIV Planning Council instructed the Columbia research team to recruit additional participants into the CHAIN study. In consultation with MHRA, the NYC Department of Health, and the HIV Planning Council, the researchers returned to the original 43 agencies for assistance in recruiting individuals more newly diagnosed with HIV. The objective of this strategy was twofold: (1) to supplement the diminishing numbers of the original cohort, and (2) to explore historical changes in New York s HIV-positive population since the original CHAIN participants were recruited. Twenty-two of the original agencies agreed to participate in the refresher recruitment. The principal reasons for non-participation among the remaining twenty-one agencies included organizational constraints (e.g., insufficient staff or time, agency in the process of moving), inability to follow through with client recruitment despite an initial agreement to do so, and for at least one agency, defunding of its HIV/AIDS program such that the agency no longer served HIV-positive clientele. Three of the twenty-one agencies did not respond at all to repeated requests to participate. Of the 22 agencies who participated in the refresher effort, 19 recruited a random sample of clients and 3 agencies conducted an open enrollment, using strategies identical to those employed at the first wave. 1 The interval between the fourth and fifth interviews was intentionally lengthened to about a year. 5

9 In order to insure that the refresher cohort was recruited from a population of more recently infected individuals, the participating agencies were asked to recruit only individuals who first tested positive for HIV after Jan 1, Despite their efforts to comply with this request, many agencies had incomplete information about their clients HIV diagnosis dates, and consequently several clients with earlier diagnosis dates were interviewed by CHAIN staff. Among the 253 refresher clients interviewed by CHAIN staff, 36 (14%) had become aware of their HIV diagnosis earlier than Jan 1, The refresher cohort differs from the original cohort in several important respects that largely reflects the changing epidemiology of HIV. Table 2 presents a comparison of the gender and ethnic composition of the continuing and refresher cohort. As a point of reference, Table 2 also includes breakdowns for the 1997 surviving AIDS cases in New York City. The original CHAIN cohort closely conforms to the surviving AIDS data, although there is an over representation of African American men and women and a corresponding under representation of white men and women. The over representation of African Americans and under representation of whites is further amplified in the refresher cohort. Comparison of additional characteristics not shown in Table 2 reveals that the refresher cohort has proportionately fewer individuals who report any history of problem drug use or same sex activity between men. There is a correspondingly larger proportion of both males and females who fall into the heterosexual/other risk behavior category. Update Report #18 presents a detailed comparison between the continuing and refresher cohorts. It also examines the extent to which cohort differences are attributable to the changing epidemiology of HIV or to differences in sample design and recruitment. Findings in this report routinely combine the two cohorts as though they were a single cohort. However supplemental statistical analyses have been performed that verify similar results obtain when analysis is performed separately for the two cohorts. 6

10 Table 2. Comparison of Epidemiological Data with Round 5 CHAIN Participants Surviving AIDS Cases, NYC Round 5 CHAIN Participants 1997 Original cohort Refresher cohort n 39, MALE 29, White 28% 21% 16% Black 38% 50% 59% Hispanic 33% 29% 28% FEMALE 10, White 12% 7% 4% Black 53% 63% 66% Hispanic 34% 29% 30% CHAIN Interviews, NYSDOH AIDS Institute All CHAIN interviews are conducted in person by trained interviewers. Interview topics include sociodemographic characteristics, the full range of experiences with access to and use of medical and social services, and quality of life. At each round of interviews participants are shown a card with a list of the generic and trade names of prescription drugs used to treat HIV-related conditions. These cards include the FDA approved nucleoside reverse transcriptase inhibitors, protease inhibitors, and non-nucleoside reverse transcriptase inhibitors. A total of sixteen antiretroviral therapies are currently included in our interview medication chart. At baseline interviews, participants were asked tell me which of these drugs [on the card] you have taken in the last six months. If you are unsure of a drug name, please tell me the specific condition that it is prescribed for. For subsequent interviews, the phrasing of the question was changed to elicit information on medications currently being taken: Please look at this card and tell me which of these drugs, if any, you are taking right now?... Are you currently taking any other prescription medicines or drugs [not listed on the card]?. Participants were also asked for the names of other 7

11 medications a doctor prescribed that were not on the card. CHAIN Technical Report # 7R contains a more detailed description of data collected in the survey and profile of CHAIN participants. Classifying Antiretroviral Therapies-- DHHS Clinical Guidelines The grouping of antiretroviral therapies in this report follows federal (Department of Health and Human Services) clinical guidelines 2 for use of antiretroviral medications. The panel responsible for the guidelines concluded that antiretroviral therapy provided clinical benefits at all stages of infection. It recommended that: C All patients with symptomatic HIV infection should be treated with antiretroviral therapy; C Physicians should discuss antiretroviral therapy with asymptomatic patients, but a physician's recommendation to treat should depend on a complex set of considerations that include CD4 T cell count, viral load, the potential long term risks and benefits of initiating therapy in asymptomatic patients, and the willingness of the patient to begin therapy; C - "... no patient should automatically be excluded from consideration for antiretroviral therapy simply because he or she exhibits a behavior or other characteristic judged by some to lend itself to noncompliance." The guidelines divided antiretroviral therapies into four categories 1. A preferred category of antiretroviral regimens with [at least] one protease inhibitor (PI) and two nucleoside reverse transcriptase inhibitors (NRTI). 2 Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents (Department of Health and Human Services, November 5, 1997). 8

12 2. An alternative recommended category combinations that include two NRTIs and a non-nucleoside reverse transcriptase inhibitors (NNRTI) or the protease inhibitor Saquinavir with 2 NRTIs. 3. A not generally recommended category that contained 2 NRTI combinations. 4. A not recommended category that contained monotherapy (except ZDV for pregnant women) and a small number of 2-NRTI combinations that have overlapping toxicities. Given the complex nature of the therapies and the rapid changes in clinical practice it would be inappropriate to draw strong conclusions about best clinical practices based only on conformity to preferred and alternative DHHS recommended categories. The guidelines make clear that the decisions about initiation of treatment and choice of drug combinations are complex. The establishment of whether a choice of combination therapy is appropriate for an individual patient requires detailed information, not available from the interview data, about a patient s prior treatment history, failure of particular drug combinations, continued success of less potent combinations, medication interactions, patient reaction to drug toxicity, and consideration of a patient s social circumstances and psychological readiness to follow complex dosing instructions. Therefore compliance with the DHHS guidelines should not be taken as a direct measure of quality of care. Nonetheless, examination of the patterns of antiretroviral medication at Time 5 with respect to the guideline categories does provide policy- relevant information for comparing the extent to which different subgroups of HIV patients are receiving what today is generally regarded as the preferred antiretroviral regimens. 9

13 Findings Trends in Antiretroviral Therapy Figure 1 and Table 3 display trends in antiretroviral therapy among CHAIN participants. Reports of antiretroviral medication at all but the first round of interviews were pooled and then grouped by the year and quarter in which interviews were conducted. This generated fourteen observations, beginning with the third quarter of 1995 through the final quarter of The beginning of this time period coincides with the introduction of combination therapy and protease inhibitors during the fall of The graph separately plots percentages of participants who report current use of any antiretroviral medication, and three subgroups of antiretroviral therapies: (1) monotherapy, (2) drug combinations that are not triple combination therapies which include a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI), and (3) highly active antiretroviral therapies (HAART), triple drug combinations that include a PI or NNRTI. Figure 1 displays both the actual quarterly percentages and a smoothed trend line for each of the four therapy groupings. Table 3 presents a tabular display of annual trends in antiretroviral therapy. The most important feature of the trends in Figure 1 and Table 3 is the stabilization of use of combination therapies at high levels, after the first six months of From the third quarter of 1997 through all of 1998, current use of combination therapies has fluctuated in a narrow range between 70 and 80 percent. During this period, just under half of the CHAIN cohort consistently reported current use of the DHHS recommended triple combination therapies. In contrast, use of monotherapy has remained well below 10 percent since the middle of 1997, and less potent combinations have remained at about the 20 percent level. These trends follow the initial rapid increase in use of combination therapies which took place from the therapies introduction in the last quarter of 1995 through the first six months of Tables 4 and 5 present more specific data on the extent to which the CHAIN cohort's use of antiretroviral therapies conforms to DHHS recommendations. Table 4 lists the most frequent antiretroviral combination reported at the fourth and fifth round of interviews. The most striking 10

14 difference between the fourth and fifth rounds is the enormous increase in the number of distinct combinations--emphasizing the bewildering therapeutic options confronting the physicians managing HIV cases. Nonetheless, the most frequent combinations listed are those that fall within DHHS preferred combinations category. 11

15 Figure 1: Trends in Current use of Antiretroviral Therapy, Table 3. Trends in Antiretroviral Combination Therapy % Type of Antiretroviral Therapy (N=) (666) (481) (517) None Monotherapy Nucleoside Reverse Transcriptase Inhibitor(NRTI) drug Combination or 2 Drug Combination with a Protease Inhibitor or Non-nucleoside reverse transcriptase inhibitor (NNRTI) or more Drug Combination with a P.I or more drug Combination with NNRTI Total Source: CHAIN Survey Times 2 through 5 12

16 Table 5 shows the distribution of antiretroviral therapies following the four groupings used by the DHHS guidelines as revised December 1, 1998 (see Table VI of the guidelines). A fifth category is added to Table 5 that includes combination therapies that do not fit within the guidelines categories. For the most part, this latter grouping is composed of two-drug combinations of a PI and a NRTI. At the time of the fifth interviews (October 1997 to November 1998), Table 5 indicates that the largest grouping of CHAIN participants were those taking antiretroviral therapies that fell within the DHHS preferred and alternative categories (42%). Only 8 percent reported taking a single antiretroviral or an undesirable combination that fell within the not recommended category. Many more participants, 17 percent, were taking a single NRTI with either a PI or NNRTI, combinations that did not explicitly fall into any of the DHHS guideline categories. Also, drop in those not taking any Rx - 33%to 23%. Based on these results, the rest of this report considers two combination therapy groups. The first encompasses any combination of two or more antiretroviral medications; virtually all combinations are believed to have some clinical benefit. The second focuses more narrowly on the most potent antiretroviral therapies that fall within the preferred and alternative categories and are regarded to have sustained clinical benefit when taken as prescribed. Table 4. Most Frequent Antiretroviral Therapies Reported at Time 4 & Time 5 (Numbers in Parentheses are count of Participants Reporting each Combination) Single Nucleoside Reverse Transcriptase Inhibitor Time 4 10/96-10/97 Time 5 10/97-11/98 12% (33) 4% (18) ZDV (17) 3TC (10) d4t (4) d4t (7) ZDV (4) 3TC (4) NRTI Combinations 25% (72) 14% (69) ZDV/3TC (36) d4t/3tc (22) d4t/ddi (7) ZDV Combos (7) d4t/3tc (31) ZDV/3TC (27) 13

17 Table 4. Most Frequent Antiretroviral Therapies Reported at Time 4 & Time 5 (Numbers in Parentheses are count of Participants Reporting each Combination) Combinations including a Protease Inhibitor or NNRTI Time 4 10/96-10/97 Time 5 10/97-11/98 63% (182) 82% (399) Indinavir/3TC/ZDV (31) Indinavir/3TC/d4T (24) Saquinavir/3TC/zdv (18) Saquinavir/3TC/d4T (11) Ritonavir/3TC/zdv ( 9) Saquinavir/3TC (7) Indinavir/3TC (6) Nelfinavir/zdv/3TC(49) Nelfinavir/d4tc/3tc(49) Indinavir/3TC/ZDV (39) Indinavir/3TC/d4T(27) Saquinavir/3TC/d4T (18) Saquinavir/ZDV/3TC (18) Nelfinavir/ddi/d4t(14) Saquinavir/3TC/zdv (11) Ritonavir/3TC/d4T (7) Saquinavir/ZDV (7) Other Combinations PI/NNRTI+2nrti s Saquinivar+Ritonavir Saquinivar Ritonavir Indinavir Nelfinavir Nevirapine other combinations Source: Time 4 CHAIN Survey

18 Table 5. Antiretroviral Therapies & DHHS Recommended Antiretroviral Agents for Treatment of HIV(Revised December 1, 1998) T4 Interviews T5 Interviews DHHS Recommendations N % of All Interviews (N=420) Preferred anti-retroviral combinations PI+2 NRTI s* N % of All Interviews (N=638) Alternative 1 NNRTI + 2 NRTIs Not generally recommended 2 NRTIs Not recommended Monotherapy Some 2 NRTI combinations Combinations not classified PI+NRTI Not on any therapy Source: CHAIN T4 & T5 Surveys * Since the interview data did not distinguish the two forms of saquinavir (Fortovase and Invirase), the preferred category may include a small but unknown number of combinations of Invirase without ritonavir as recommended. Participant and Provider Characteristics Associated with Use of Antiretroviral Therapies The next series of tables present CHAIN data that explore potential participant and provider influences on the use of combination therapy. The factors examined for this analysis are grouped into six domains: (1) clinically relevant criteria, (2) participant sociodemographic characteristics, (3) current risk behaviors and social circumstances, (4) social support, (5) characteristics of medical care, and (6) insurance coverage. 15

19 Presentation and Methods of Analysis In the main body of the report, findings are presented in tabular form. The tables show how each characteristic is associated with the differences in the percentage of those currently using any combination of antiretroviral therapy and those who are taking 3 or more drugs that conform to the DHHS recommendations. Multiple regression analysis was also performed for a more refined assessment of the way participant and provider characteristics influence use of combination therapy. As appropriate, the text takes note of results of the regression analysis that clarify tabular presentations. The interested reader is directed to the report appendix for a more detailed presentation of the regression methodology and findings Antiretroviral Therapies and Stage of Disease The percentage of the CHAIN participants taking a combination therapy at Time 5 increased significantly with declining CD4 T-Cell count and an AIDS diagnosis (see Table 6), but it was unrelated to length of time people have been aware of their infection. Current use of combination therapy reaches a very high level of coverage for people who at some point in time had reached what formally might have been the end stages of the disease. Among CHAIN participants who at Time 3 reported a CD4 T-Cell count below 100, 88 percent reported taking, at Time 5, some combination of medications, and 51 percent were taking a combination that included a protease inhibitor. At the other end of the disease spectrum, a much smaller, but a still sizable minority of CHAIN participants, who were asymptomatic or had a CD4 T-Cell count above 500, were taking combination antiretroviral medications. This pattern is consistent with findings from earlier rounds of interviews, but it is interesting to observe that the range of values across CD4 categories at Time 5 interviews is considerably reduced from Time 4. This is due to large inter-wave increases in current use experienced at all CD4 count levels, except for those in the lowest CD4 count group (0-100). 16

20 Table 6. Antiretroviral Therapy and Stage of Disease % on Any Combination Therapy 1 % DHHS Recommended Therapies 2 All Participants 3 (N=420/638) Time 4 10/96-10/97 Time 5 10/97-11/98 Time 4 10/96-10/ Time 5 10/97-11/98 CD4 T-Cell Counts 4 >500 (90/88) (104/97) (56/50) (71/68) (86/72) *** *** *** * Stage of Disease 5 Asymptomatic (43/117) Symptomatic (38/85) AIDS (339/436) *** ** * Year of HIV+ diagnosis ( 244/241) ( 176/275) ( 0/ 122) Source: CHAIN Surveys, Times 3 through 5 *p #.05 **p #.01 ***p # Currently taking two or more antiretroviral medications 2 Currently taking a preferred or alternative antiretroviral therapy according DHHS Guidelines 3 Time 4 sample size/time 5 sample size 4 CD4 T-Cell Counts are measured for Time 3. 5 In staging disease, individuals stay in the same stage or progress to more advanced stage. Thus, once diagnosed with AIDS, CHAIN participants stay in this category regardless of subsequent improvement in T-Cell counts or absence of symptoms. Race/ethnic differences Large race and ethnic differences in use of antiretroviral therapy that were present in the months immediately following the introduction of combination therapies have greatly diminished to the point that race and ethnic differences are no longer statistically significant at round 5 17

21 interviews. (See Table 7 and Figure 2) African Americans, however, continue to lag slightly behind Latinos and non-hispanic whites. Figure 2: Trends in Current Use of Antiretroviral Therapy by Race/Ethnicity

22 Table 7. Antiretroviral Therapy and Sociodemographic Characteristics % on any Combination Therapy 1 % DHHS Recommended Therapies 2 Time 4 10/96-10/97 Time 5 10/97-11/98 Time 4 10/96-10/97 Time 5 10/97-11/98 All Participants (N=420/638) (T4/T5) Gender Male (252/367) Female (168/270) * Race/Ethnicity Black, NonHispanic(226/369) White, NonHispanic(70/85) Hispanic (119/176) ** *** Years of Education Less than H.S. (169/292) H.S. Grad (105/156) Some College (94/133) College Grad (51/56) *** Borough of Residence Bronx (128/193) Brooklyn (93/127) Manhattan (132/157) Queens (39/58) Staten Island ( 23/42) ** Source: Time 4 and Time 5 CHAIN Surveys *p #.05 **p #.01 ***p # Currently taking two or more antiretroviral medications 2 Currently taking a preferred or alternative antiretroviral therapy according DHHS Guidelines 19

23 Other sociodemographic characteristics The influence of other sociodemographic characteristics have also greatly diminished in the most current time period. For fifth round interviews, neither gender, educational attainment nor borough of residency are associated with use of combination therapies (see Table 7). Current risk behaviors and social circumstances In contrast to the diminishing influence of sociodemographic characteristics, current social circumstances continue to play a role in use of combination therapy. Table 8 indicates that current drug use, as defined by problem drinking or any use of heroin or crack /cocaine during the six months prior to the interview is associated with only a modest reduction in the use of combination therapy. In contrast unstable housing situations--defined as either being doubled up with a friend or a relative or living in an SRO, shelter, on the streets or in some other temporary or transitory living situation had a stronger impact on reducing current use of any combination therapy as well as DHHS recommended combinations. Table 9 does show that the salient unstable housing category shifts between the forth and fifth round of interviews from the unstable or transitory housing situations to being doubled-up. The reason for this shift is not apparent. More importantly, the regression analysis confirms that unstable housing situations are among the strongest impediments to the use of combination therapies when the two categories are combined. To assess the influence of patient mental health on use of combination therapy, we have constructed a measure of low mental health functioning based upon a widely used quality of life measure, the Medical Outcomes Study SF-36. Scale values may range from 0 to 100 with lower values indicating poorer mental health. Two points on this scale were used to identify individuals with low mental health functioning. Scores that fall below 37.0 (the Low-Low grouping under Mental Health Functioning in Table 8) has been shown to be strongly associated with high need for mental health services. Table 8 shows a modest association between low mental health functioning and lower use of the DHHS recommended combinations. However, the regression analysis strengthens support for a substantial negative relationship between low mental health functioning and use of the more potent antiretroviral combinations. 20

24 More detailed examinations of combination therapies among alcohol and drug users and people with low mental health functioning are examined separately in a later section of this report. Table 8. Risk Factors and Current Life Circumstances % on Any Combination Therapy 1 % DHHS Recommended Therapies 2 Time 4 10/96-9/97 Time 5 10/97-11/98 Time 4 10/96-9/97 All Participants (N=420/638) Time 5 10/97-11/98 Problem Drug Use Current Problem (118/127) Past Problem (221/354) No Problem (81/57) Housing Situation Stable (327/494) Doubled Up (46/63) Unstable (47/81) ** ** Mental Health Functioning 3 Normal (258/400) Low (162/238) Low-Low (127/185) SPMI (113/110) * Source: Time 4 and Time 5 CHAIN Surveys *p #.05 **p #.01 ***p # Currently taking two or more antiretroviral medications 2 Currently taking a preferred or alternative antiretroviral therapy according DHHS Guidelines 3 Normal functioning=42 or higher, low= less than 42, low-low=less than 37 spmi (severe and persistent mental illness= low-low mental health functioning at three or more interviews (T1 to T5) 21

25 Family Structure and Social Support As part of the analysis of participant characteristics, we have included three measures of social and family support system. Providers may be more inclined to recommend combination therapy if they know that their patients have family and friends who can assist them in taking their medications. The presence of a large circle of supportive family and friends may also have a more direct influence on initiation of combination therapy. Caring family and friends may encourage people who might otherwise have concerns about their safety and efficacy to take these medications. By contrast, people who have not disclosed their HIV status to many family and friends may not want to start therapy for fear that a heavy medication regimen may reveal their HIV status to others. There is some anecdotal evidence that friends and family, particularly those with HIV, may be influential sources for discouraging use of combination therapy. Child rearing responsibility, particularly in single-parent households, may be an additional demand that inhibits use of complex medical regimens. Drawing upon CHAIN study s rich information on social support, a household composition variable was constructed that ordered study participants with respect to the presence of the adult in a participant s household. Among participants who lived in households with other adult members, we distinguished participants who lived with a partner or spouse, from those without a partner or spouse but who lived instead with a parent or another adult. We also tabulated the number of children under 18 under the participant s care. A broader measure of supportive HIV social networks was constructed based upon the number of relatives and friends aware of the CHAIN participant s HIV infection. 22

26 Table 9. Family Structure and Social Support % on Any Combination Therapy 1 % DHHS Recommended Therapies 2 Time 4 10/96-10/97 Time 5 10/97-11/98 Time 4 10/96-10/97 All Participants (N=420/638) Time 5 10/97-11/98 Household Composition Lives with Partner or Spouse (105/156) Lives with parent (30/41) Lives with other adult (26/38) No other adult in household (259/403) Number of Dependent Children 0 (324/504) 1 ( 56/ 61) 2 ( 24/ 39) 3+ ( 16/ 34) * Number of Friends or Family who know you are HIV+ 0 ( 30/ 49) 1 ( 33/ 33) 2-4 ( 64/124) 5-9 ( 95/161) 10+ (194/271) ** Source: Time 4 and Time 5 CHAIN Surveys *p #.05 **p #.01 ***p # Currently taking two or more antiretroviral medications/ 2 Currently taking a preferred or alternative antiretroviral therapy according to DHHS Guidelines Table 9 shows that there is no consistent relationship between household structure and use of combination therapy, at either the fourth or fifth round of interviews. There is suggestive evidence that child care responsibility (number of one s children under 18 living with participant) is associated with lower use of the more potent antiretroviral combinations, at both the fourth and 23

27 fifth interviews. The inhibiting effect of living with dependent children is most evident in the use of DHHS recommended combinations, and among the small number of participants responsible for 3 or more children. The strength and statistical significance of this relationship is confirmed by the regression analysis. At both rounds of interviews, use of DHHS recommended combination therapy exhibits a weak and not very consistent tendency to increase as the number of friends and family who are aware of one s HIV status increase. Despite the weakness of this observed association, this variable is among the stronger correlates of the use of DHHS recommended combinations in the regression analysis. Medical Care and Insurance Coverage Tables 10 and 11 summarize the relationship between use of a combination therapy and the source of medical care and the type of insurance coverage. Besides the organizational setting in which participants received their medical care, several measures of the character of medical care and satisfaction with the provider-patient interaction are examined. A measure of the continuity of medical care was constructed by comparing whether the facility where medical care was provided had changed between interviews. About 40 percent of the sample reported receiving their medical care at the same facility, at each of the five rounds of interviews. (analysis of this factor was necessarily limited to the 385 participants from the continuing cohort) We also considered whether participants current medical care embodied three attributes associated with primary care: comprehensiveness, coordination, and 24-hour access 3. Table 10. Source and Characteristics of Medical Care 3 CHAIN interviewers are trained to ascertain that 24-hour access refers to a formal arrangement by the provider designed to secure appropriate medical care, excluding going to an emergency room. The actual question participants are asked is the following During the last six months, was there always someone you could call 24 hours a day in case of a medical emergency? For example, being given your medical provider s beeper which is on 24 hours a day qualifies as having 24-hour access. 24

28 % on Any Combination Therapy 1 % DHHS Recommended Therapies 2 Time 4 10/96-10/97 Time 5 10/97-11/98 Time 4 10/96-10/97 All Participants (N=420/638) Time 5 10/97-11/98 Source of Medical Care Private Practice (60/64) HHC Clinic (76/105) Voluntary Hospital Clinic (178/290) Freestanding Clinic (55/84) Other (36/72) ** Continuity of Medical Care Has Same Provider Since Time 5 Interview ( NA/102) Time 4 interview (126/ 61) Time 3 Interview ( 44/ 26) Time 2 Interview (35/ 26) Time 1 Interview (203/154) *** Saw a Physician Six months Before interview Yes (397/605) No (223/ 33) *** *** * 49 9 *** Has Access to Comprehensive & Coordinated Medical Care Yes (249/392) No (171/246) *** *** * Source: Time 4 and Time 5 CHAIN Surveys *p #.05 **p #.01 ***p # Currently taking two or more antiretroviral medications 2 Currently taking a preferred or alternative antiretroviral therapy according DHHS Guidelines Not surprisingly the most important aspect of medical care related to use of combination therapy was current access to medical care. Although virtually all CHAIN participants report having 25

29 a current provider, a very small number (n=33 at Time 5) did not report a physician visit within six months of their interview. Very few of these participants reported current use of any antiretroviral combination (18%) or use of DHHS recommended therapies (9%). The strong advantage of receiving care at a private practice on use of DHHS recommended therapies evident at Time 4 had entirely disappeared by Time 5. In contrast access to comprehensive and coordinated medical care continues to be associated with higher use of combination therapy at Time 5. There is a significant but not entirely consistent relationship between use of combination therapy and longer association with the same medical care organization. Table 11 shows that having insurance coverage, but not the type of coverage, clearly matters in obtaining combination therapy. Among the very small number of uninsured CHAIN participants at Time 5 interviews (n=14), only 29 percent reported using a combination therapy. In sharp contrast, among insured CHAIN participants, the proportion taking combination therapies exceeded 70 percent regardless of type of insurance coverage. Enrollment in ADAP+ is associated with increased use of combination therapy. There are too few CHAIN participants enrolled in private or Medicaid managed care organizations to draw any meaningful conclusions about the effect of managed care on access to these medications. 26

30 Table 11. Insurance Coverage and Antiretroviral Therapy % on Any Combination Therapy 1 % DHHS Recommended Therapies 2 Time 4 10/96-10/97 Time 5 10/97-11/98 Time 4 10/96-10/97 All Participants (N=420/638) Time 5 10/97-11/98 Type of Insurance Private (45/59) Medicaid (284/430) Other Public Insurance(79/135) Uninsured (12/14) ** *** Enrolled in ADAP+ Yes ( 42/ 82) No (378/556) * ** Enrolled in a Managed Care Plan Yes, Private (32/33) Yes, Medicaid (16/20) No, Private (15/28) No, Public (347/403) ** Source: Time 4 and Time 5 CHAIN Surveys *p #.05 **p #.01 ***p # Currently taking two or more antiretroviral medications 2 Currently taking a preferred or alternative antiretroviral therapy according DHHS Guidelines Third Party reimbursement Table 12 summarizes CHAIN participants third party reimbursement for antiretroviral therapy. This table shows the source of reimbursement for each type of antiretroviral medication reported by CHAIN participants. For example, CHAIN participants reported current use of 738 different NRTI s (this count includes multiple medications reported by a single participant). 27

31 Consistent with findings from previous interviews, our sample overwhelmingly depends on government programs to cover the cost of antiretroviral medications. Medicaid is by, by far, the single most common source of payment for antiretroviral therapy. Medicaid pays for medication for about 80 percent of NRTI and PI medications. ADAP is a distant second source and private insurance pays for only a very small fraction of all medications. Table 12. Third Party Reimbursement for Antiretroviral Therapy Time 5 Interviews (10/97 to 11/98) % Reimbursement for NNRTIs (n=) Medicaid Private Insurance ADAP Reimbursement for Reverse Transcriptase Inhibitors (n=) Medicaid Private Insurance ADAP Reimbursement for Protease Inhibitor (n=) Medicaid Private Insurance ADAP (42) (738) (408) Source: Time 5 CHAIN Survey Subgroup Analysis of Recent Alcohol and Other Drug Use and People with Mental Health Problems Because mental health disorders and alcohol and drug problems present special health care issues for clinical management of antiretroviral therapy, we conducted separate analysis for subgroups of CHAIN participants, who either reported recent alcohol and drug use or self-reported mental health symptoms that are highly indicative of need for mental health services. 28

32 Alcohol and Other Drug Use To investigate the possible consequences of use of alcohol and other drugs (AOD) on access and use of combination therapy, we selected a group of CHAIN participants at each interview whom we refer to as recent AOD Users. Such individuals report use of crack, cocaine, heroin and alcohol consumption five or more times in their life and report use of crack/cocaine or heroin at least once during the six months that precede the interview, or reported a pattern of drinking within six months of the interview that is associated with problem drinking. Figure 4 displays trends in use of combination therapy for recent AOD users, those with past drug use, and those reporting no past drug use. The graphs in Figure 4 and the accompanying tabular data show that recent AOD users have experienced increases in use of combination antiretroviral therapies, similar to participants with no recent AOD use. Nonetheless, recent AOD use is associated with a relatively constant deficit in current use of combination therapies between 1996 and However, as reported earlier, the lower use associated with current AOD does not reach differences of statistical significance. 29

33 Figure 4: Alcohol and Drug Problems -Trends in Antiretroviral Therapy Alcohol and Drug Problems Last Six Months Past Never 32% 41% 50% 58% 67% 65% 65% 74% 78% Alcohol and Drug Problems Last Six Months Past Never 8% 16% 16% 33% 45% 41% 41% 46% 51% 30

34 Table 13 examines current use of combination therapy for different types of recent drug users, in which we have selected out regular users of heroin, crack/cocaine and problem drinkers. All subgroups of recent AOD users have experienced large increases between the 4 th and 5 th interviews in use of any combination therapy as well as use of the more potent DHHS recommended therapies. Nonetheless it is also clear that regular crack/cocaine users account for much of the difference in use of combination therapy associated with AOD. Table 13. Use of Antiretrovrial Therapy at 4 th and 5 th interviews by Type of Recent Drug Use % Taking Any Combination Therapy % Taking DHHS recommended Therapies Drug Using Patterns in Last 6 months Time 4 10/96-10/97 Time 5 10/97-11/98 Time 4 10/96-10/97 Time 5 10/97-11/98 All Participants (420/638) Any Recent Use of Crack, Heroin or Problem Drinking (118/127) Type of Drug Used Crack or Cocaine 3+ /wk (26/31) 42* 55* Problem Alcohol Use (38/47) Weekly use of Heroin (17/23) Other Current Users (53/47) A small number of participants fall into the problem alcohol and regular crack/cocaine categories. The other use category are participants who report less than weekly use of heroin or crack in the last six months. + Differs at the p<.1 level of statistical significant from those reporting no recent use of drugs or problem alcohol use *Differs at the p<.1 level of statistical significant from those reporting no recent use of drugs or problem alcohol use Next we consider whether recent AOD users differ from other CHAIN participants with regard to individual and provider characteristics that influence use of combination therapy. Each of the characteristics examined for the full CHAIN cohort was re-analyzed just for recent AOD users. The analysis indicates that the influences on recent AOD users are generally similar to those 31

35 for the cohort as a whole. However our data suggest that there are AOD-specific patterns with respect to the influence of ethnicity and housing arrangements. In contrast to the general absence of large ethnic differences, use of combination therapy is much lower among recent AOD minority users compared to recent AOD non-hispanic white users (N=20) (see Table 14). Table 14: Race/Ethnic Differences in Use of Combination Therapy by Recent AOD Use. % Used Any Combination Therapy Recent AOD Use? % DHHS Recommended Therapy Recent AOD Use Race/Ethnicity Yes No Yes No White, NonHispanic Black, NonHispanic Hispanic Source: Time 5 CHAIN Interviews Housing situation also appears to operate somewhat differently among recent AOD users. Although being doubled up is associated with lower level of current use of combination therapies than living in a stable household or unstable housing situation, its impact is much more severe for recent AOD users (see Table 5). Furthermore, the analysis indicates that the unstable living situation category is not associated with diminished use for recent AOD users as it is for other CHAIN participants. Perhaps health care providers are more attentive to reaching out to people with both transitory housing situations and drug use, rather than those with only a single vulnerability. 32

36 Table 15: Housing Status and Use of Combination Therapy by Recent AOD Use. % Used Any Combination Therapy Recent AOD Use? % DHHS Recommended Therapy Recent AOD Use Housing Situation Yes No Yes No Stable Doubled Up Unstable Source: Time 5 CHAIN Interviews Mental Health For this analysis, 37 on the mental health functioning is used as the divider between low mental health functioning individuals and all other individuals. The graphic and tabular presentations in Figure 5, show that use of any combination therapy is very similar for low and normal mental health functioning, but there appears to be a constantly increasing difference over time when it comes to the DHHS recommended combinations. An examination of the influence of other patient and provider characteristics, reveals no large differences between the operation of these variable on use of combination therapy for people with low mental health and those with normal functioning. 33