Community-Level HIV Prevention Trials: Design, Implementation and Effectiveness

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1 Community-Level HIV Prevention Trials: Design, Implementation and Effectiveness Kathleen J. Sikkema, Ph.D. Duke University Professor of Psychology and Neuroscience Research was supported by grant R01-MH42908 from the National Institute of Mental Health (NIMH) and by NIMH center grants P30- MH and P30-MH62294

2 About 7,400 new HIV infections a day in 2007 More than 95% are in developing countries Almost 1,015 are in children under 15 years of age About 6,300 are in persons aged 15 to 49 years, of whom: 50% are women 45% are year olds

3 State-of-the-Science HIV Primary Prevention Face-to-Face and Individual Group Interventions STD Clinics Health care clinics Homeless shelters Community based agencies

4 Conceptual Components of Interventions Relationships HIV risk and knowledge Environmental management/ problem-solving Condom skills Negotiation/communication Maintenance and relapse prevention

5 Community-Level Interventions Diffusion of Innovation Theory (Rogers) Social Cognitive Theory (Bandura)

6 Social Cognitive Theory

7 What is Diffusion? Innovation: idea, practice or object perceived as new Communication channels by which messages are exchanged Time, or process Social system: structure and function of relations among individuals

8 Diffusion Concepts for Targeted Groups Process over Time Opinion Leaders Decentralized Diffusion Systems Change Agents Compatibility

9 Community-Level Trials Change social networks and communities to reinforce risk avoidance and risk reduction efforts Potential to reach large numbers of people Be cost-effective Feasible for implementation in areas with limited resources

10 Community Intervention Projects: United States Men from gay bars in small cities Women in low-income housing developments Adolescents in urban housing developments

11 Gay Bars in Small Cities Kelly JA, Murphy DA, Sikkema KJ, et al. Randomized, controlled, community-level HIV prevention intervention for sexual risk behavior among homosexual men in US cities. The Lancet. 1997; 350:

12 Community-Level Intervention with Gay Men Gay bars as community Enlist opinion leaders to endorse change Five group sessions Focus on conversational messages and social norm changes

13 Research Methodology 8 Cities: 4 pairs Survey of all men Baseline & 1-year follow up Excludes transients and exclusive partners

14 Mean Frequency Of Unprotected Anal Intercourse In The Past Two Months Baseline One Year Follow- Up Intervention Cities Control Cities

15 Women in Low-Income Housing Developments Sikkema KJ, Kelly JA, Winett RA, et al. Outcomes of a randomized community-level prevention intervention for women living in 18 lowincome housing developments. American Journal of Public Health. 2000; 90:

16 Formative Research Phase Preliminary studies to confirm risk Individual elicitation interview Focus Groups Key informant interviews and meeting

17 Scope of Project Seattle/Tacoma, WA Milwaukee, WI Rochester, NY Cleveland, OH Roanoke, VA 18 Housing Developments Moderate size ( units); cluster-type developments Female heads of household

18 Research Design Baseline Community Intervention Follow-Up Baselin e Brochures And Condoms Follow-up 18 months

19 Community Intervention Elements Women s Health Council Skills Training Workshops Community Activities and Events

20 Community-Level Assessments Over 80% of female residents age 18 and older Anonymous self-report survey Small group administration Identification of opinion leaders

21 Baseline Results 1,265 females Mean age 33.8 (range 15-86) 75% African American 20% White 3% Hispanic/Latina 2% Other Mean number of children 2.8 (range 0-15)

22 Statistical Methods Nested cohort design model Housing development as unit of analysis Mixed model generalized linear model approach

23 Intercourse Occasions with Intervention Condoms Comparison Pre- Intervention 12-Month Follow-Up Significance with development as unit of analysis, df=1, 16; p<.01

24 Any Unprotected Intercourse Pre- Intervention 12-Month Follow-up 0 Intervention Comparison Significance with development as unit of analysis, df=1, 16; p=.03

25 Conclusions Community intervention models can change risk behaviors among women in impoverished neighborhoods Key opinion leaders can mobilize community-based HIV prevention efforts Interventions must be targeted and tailored Collaboration with the community is necessary for development, implementation, and continuation

26 HIV Prevention Among Adolescents Skills training interventions are state-ofthe-science Interventions focused on individuals Limited studies targeted to pre- or early adolescence Focused on abstinence outcomes with conflicting findings Most are school-based Long term effectiveness is limited Need for interventions that change social networks and communities

27 Can HIV prevention efforts be improved and better maintained by Skills training to enact behavior change AND Community-level intervention that provides modeling, peer norm and social reinforcement for reducing or avoiding HIV risk behavior? Sikkema et al. Outcomes of a randomized, controlled community-level intervention for adolescents in low-income housing developments. AIDS. 2005;19:

28 Research Design Community: Baseline Skills Short-term Follow-up Community Component Long-term Follow-up Skills: Baseline Skills Short-term Follow-up Long-term Follow-up Control: Baseline Education Short-term Follow-up Long-term Follow-up 18 months

29 Scope of Research Seattle/Tacoma, WA Milwaukee, WI Roanoke, VA 15 Housing Developments 5 sets of three matched developments adolescents

30 Assessments 85% of all adolescents at baseline Self administered, audio-assisted computer survey Behavioral and psychosocial measures based on social cognitive theory 74% completed 3-month (Short-term follow-up) 65% completed 9-month (Long-term follow-up)

31 Baseline Results 1172 adolescents (587 males, 585 females) Average age = th grade education 99% attending school 73% not yet in high school Study Cohorts vs. Baseline Only Younger; lived in development longer Less likely to : have had sex use substances have had an STD

32 Racial/Ethnic Characteristics Ethiopian Native American Russian Hispanic Ukranian Cambodian (n = 1172) Other Asian Somalian African American Eritrian Causasian Vietnamese

33 Sexual Activity Among Cohort Adolescents at Baseline 27% had sexual intercourse 76% condom use last intercourse Average age first intercourse: 12.5 years Average of 4 sexual partners past year 11% had anal intercourse past 3 months 9% ever had STD

34 Skills Training Skills Training Group Intervention State-of-the-Science cognitive- behavioral skills training Condoms and brochures available Two sessions (6 hours total) Groups by age and gender Delay/refrain from sexual activity Consistent condom use if sexually active Systematic selection of peer leaders

35 Pre-Community Component Activities Social Events/Movies Follow-up Session Systematic Selection of Peer Leaders Focus Group and Team Building

36 Community Component Teen Health Council of Peer Leaders Program Activities: 4ME participants Small Media: Prevention messages Community Wide Events Parent Workshops: HIV/AIDS and Talking to Your Children

37 Research Design Community: Baseline Skills (87%) Short-term Follow-up Community Component Long-term Follow-up Skills: Baseline Skills (87%) Short-term Follow-up Long-term Follow-up Control: Baseline Education (15%) Short-term Follow-up Long-term Follow-up 18 months

38 Statistical Methods Nested cohort design model Housing development as unit of analysis Mixed model ANCOVA approach

39 Initiation of First Intercourse Among Those Not Sexually Active at Baseline 40 Percent Short-term follow-up (n = 644) NS Long-term follow-up (n = 577) NS ; p <.05 ; p <.10

40 Abstinence Intervention Long-Term Effects with Regression Adjustments Females continue sexual abstinence Abstinence declined as age increases No partner in previous year remained abstinent No interactions of effect of treatment and effect of gender Psychosocial variables: Higher risk reduction intentions Lower condom use outcome expectations Fewer risk reduction behavioral skills

41 Proportion of Adolescents Using a Condom at Last Intercourse at Short- and Long-Term Follow Up Percent Short-term follow-up Long-term Follow-up p<.01 ; p<.10; NS P <.05; p <.05; NS

42 Condom Use Intervention Effects with Regression Adjustments Short-Term Follow-Up No influence of demographic characteristics or sexual activity status at baseline Social cognitive variables: Stronger perceived partner norms for condom use Greater condom use self-efficacy Long-Term Follow-Up Condom use decreased with age No difference by gender, city, or sexual activity status at baseline Social cognitive variables: Higher abstinence self-efficacy/outcome expectations More condom behavioral skills Fewer refusal skills

43 Conclusions Community intervention was shown to be more effective in delaying onset of first intercourse Impact on condom use more complex: community and skills workshop interventions both increased condom use Large scale community interventions may be most appropriate for prevention efforts among those not yet sexually active Interventions need to be targeted and tailored for subsets of high risk youth Community collaboration is necessary for the development, implementation and continuation of HIV prevention programs

44 Dormitories: Vocational and Trade Schools

45 St. Petersburg, Russia

46 Assessment Implementation NIMH Collaborative HIV/STD Prevention Trial. AIDS 2007

47 NIMH Collaborative HIV/STD Prevention Trial Adapt community level intervention (POL) to multiple cultures and populations in five countries: China India Peru Russia Zimbabwe Test intervention efficacy using behavioral and biological outcomes Develop prototype for technology transfer process NIMH U10 mechanism: co-sponsored by NIH Fogarty International Center

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