Contextual influences on product preference : Lessons from MTN studies

Transcription

1 Contextual influences on product preference : Lessons from MTN studies Ariane van der Straten, PhD, MPH Women s Global Health Imperative RTI International San Francisco, CA, USA NIH: The role of relationships in HIV prevention among Young Women in Africa Meeting September 4, 2014

2 Presentation outline MTN001: gel/tablet preference: geography and sex differences VOICE-C: contextual issues influencing gel/tablet preference VOICE-D: hypothetical & real products ASPIRE: involving men and other source of influences (e.g. peer participants) to support trial engagement & product use 2

3 MTN001: product preference varies by sex and geographical context 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Women's product preferences (N=144) African Study Sites U.S. Study Sites Women s perceptions of male partner s preferences (N=118) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% African Study Sites U.S. Study Sites 0% Vaginal gel Oral tablets Both liked equally Neither liked 0% Vaginal gel Oral tablets Both liked equally Neither liked Minnis et al., AIBE

4 MTN001: Factors associated with preference in Africa Unmarried women: more likely to prefer gel (p=0.04) Condom use: No male condoms were used for contraception among women who had a preferred product (p=0.03) No recent condom use at baseline was associated with preferring tablets (p=0.09) Partner s knowledge (p=0.01): among women whose partners did not know about product use 73% preferred the gel 13% preferred the tablets 13% had no preference No association w/ age, education, risk (HIV worries, # partners, sexual frequency)

5 VOICE, VOICE-C, and VOICE-D VOICE: N= countries, 15 CRS (sites) VOICE-C: N=102, 22, 17 CAB, & 23 community stakeholders 1 country, 1 CRS (Joburg) VOICE-D: Stage 1, N=88 Stage 2, N=131 3 countries, 5 CRS (Kampala, Chitungwiza, Durban) 5

6 Timelines: VOICE, -C and -D PK results 6

7 VOICE-C Design & Approach Design: Exploratory sub-study of VOICE using multiple qualitative research methods at Wits-RHI (Joburg) site Study Population Female VOICE Participants Male Partners of VOICE Ppts N Selection Data Collection Method 102 Random IDI EI FGD 22 Systematic: permission requested of partner IDI FGD CAB Members 17 Purposive FGD Key Community Stakeholders 23 Purposive FGD IDI=in-depth interview; EI=ethnographic interview; FGD=focus group discussion 7

8 Socio-Ecological Framework (SEF): Levels of Influence on product use Community Organizational Household Norms Beliefs HIV Work Clinic: staff, other women Resources Life events Family Friends Male partner Individual Product attributes Side effects van der Straten et al., PLOS ONE

9 VOICE-C: Themes influencing product experience Valued clinic services and environment Concerns about trial safety & legitimacy: fueled by stories in the waiting room & community Ambivalence towards research Preserving a healthy status Women joined VOICE for health reasons Clinic services contribute to sense of well-being Product perceived as medications for sick people Selective disclosure: mitigate social risk/gain support Mis-understanding: Partners, friends, family questioned product use Managing social relationships van der Straten et al., PLOS ONE

10 Factors affecting perceptions about ARV for PrEP Social- Structural HIV stigma HIV/AIDS trivialization Community Organizational Household Individual ARV for treatment versus PrEP Rumors around research Potency and monetary value of ARVs Researchers motivations/mistrust Investigational products (active vs. placebo) Product ingredients; mechanism of action Misattribution of seropositivity Suspicion; discrimination Privacy needs for storage and usage Disclosure and (lack of ) support ARV potency, protection, safety, side effects Dosage form preference van der Straten et al., AIDS Impact 2013; JIAS in press 10

11 Socio-Ecological Framework (SEF): Influences on product preference Community Organizational Household Norms Beliefs HIV Work Clinic: staff, other women Resources Life events Family Friends Male partner Individual Product preferences 11 van der Straten et al., PLOS ONE 2014

12 Product preference: she said; he said 100% Women s Preference (N=62) 100% Men s Preference (N=14) 2/2 90% 80% 17/22 Vaginal Group Oral Group 90% 80% 9/12 Vaginal Group Oral Group 70% 70% 60% 60% 50% 18/40 50% 40% 30% 13/40 40% 30% 20% 4/22 6/40 20% 2/12 10% 1/22 3/40 10% 1/12 0% Vaginal Gel Oral Tablet Both liked Neither liked 0% Vaginal Gel Oral Tablet No preference 12

13 Gel: favored & disfavored attributes in Social- Structural Lack of familiarity with vaginal formulations Vaginal wetness : diseased ; loose Community Gel not associated with HIV Organizational Household Individual Positive waiting room stories Private (applicators can be hidden) Novelty lubricate/improved sex Vaginal cleansing Easy to insert/remove Acts locally Favored Problem to use at work Negative waiting room stories Wetness during sex partner complaints Not stealth Not discreet (privacy to insert, and store) Wetness/ leakage Discharge Insertion is intimidating Burdensome to insert Disfavored 13

14 Tablets: favored & disfavored attributes in Social- Structural Pills taken for a variety of indications HIV stigma Community Organizational Portable for travel, commuting to work Positive waiting room stories Pills associated with HIV seropositivity ARV pills recognizable Negative waiting room stories Household Simpler to take Friends use tablets Missattribution of seropositivity Individual Novelty Familiarity Systemic/potent Size/tough to swallow Urine smells Side effects/on body Favored Disfavored 14

15 Male partners Male partners displayed poor understanding of the purpose of the research and the study products Led to suspicions about intention of researchers or harmful side effects discouragement of use Some male partners had no problems with products. Mostly they were ambivalent few examples of enthusiasm and support. Male partner narratives about study participation and product use were higher-level ; typically varied little by product type. However, for gel contrasting experiences reported: in FGD disliked that gel changed the natural feeling of sex and increased wetness, whereas an IDI partner liked that partner could go for more than 2 rounds of sex without getting dry

16 VOICE-D Design & Approach Design: Qualitative exploratory study Sample Stage 1 (N=88) Former VOICE participants on product >3 months Sample stage 2 (N=131) Former VOICE participants on product >3 months Selection Pre-selected based on: Anal sex report (ACASI) HIV status (+ and -) Study product (tablets & gel) Selection Pre-selected based on: Plasma drug PK detection (low, inconsistent, high) HIV status (+ and -) Study product (tablets & gel) Data Collection Method IDI Data Collection Method IDI FGD (only with HIV-, low / inconsistent PK results) 16

17 Stage 2 Study Tools Local press clippings PK results Teapot tool Theme identification cards Potential Product Formulations 17

18 Stage 2 Participant Background Characteristic Percent (N=131) Site Durban (MRC) 24% (32) Kampala (MU-JHU) 39% (51) Chitungwiza(UZ-UCSF) 37%(48) PK result group Low 65% (85) Inconsistent 20% (26) High 15% (20) HIV Positive 13% (17) Enrolled in Stage 1 34% (45) Age (mean, range) 28 (29.2, 21-41) Completed secondary school or more 39% (50) Married 55% (72) Same partner as in VOICE 79% (95) 18

19 Products preferred* (IDIs N=68) Injectables Implants Ring oral tablet suppository Film gel CB 0% 5% 10% 15% 20% 25% 30% * Multiple selections allowed (median 2; range 0-6) 19

20 MTN 020 (ASPIRE) Phase 3 RCT of dapivirine ring 4 countries/ 14 sites: Malawi, RSA, Uganda, Zimbabwe N~2,600 enrolment done (6/14) End of study: Q months of ring use Monitoring use: visual inspection of used rings & drug levels (site blinded) Qualitative component (serial IDIs, exit FGDs) 6 sites; 96/210 enrolled Ppt engagement (PE) activities (started 3/14).

21 Integrated approach. Within sites Across sites At operations management and leadership, levels Behavioral Clinical Comm & Ppt Engagement 21

22 Behavioral measurements & activities Ring assessments and use monitoring: Ring counts & collection (accountability, visual inspection) Ring residual drug level & plasma PK (site level-blinded) Self-reports: ACASI & FTFI New! PUEV: Social influence CRF Qualitative Component Motivations to join/stay Exploration of user experience, relationships & contextual issues Potential product preferences (at Exit) PE activities: site initiated & focused Goal: to engage and reach all participants (& partners) Assessed at sites via activity logs Participant feedback via: SEV CRF, qualitative component Adherence Counseling & Education (ACE) Modeled after NSC: focus on needs & experience (based on IMB model and MI) Integrates product adherence and visit retention PE activities Ring C&C ACASI/ FTFI RING experience acceptability adherence QUAL ACE

23 Summary & lessons learned Socio-structural level & community influences Community rumors and HIV stigma persist, and fuel women s fears about research and investigational products. Three broad fears: 1) products may be harmful to their health; 2) foreigners with malintention; 2) association of products with HIV and ARV for treatment. Organizational influences Waiting room stories: peer participants influence is important being addressed and measured more carefully in ASPIRE. Male partners influences Male partner product preference not necessary aligned with that of women. Partners more supportive when they know more about, and understand purpose of, study. Although partners reluctant to present at clinic, direct engagement with research doctors was valued and requested- More male 23 engagement/couple activities are leveraged at each sites in ASPIRE.

24 Study Teams MTN-001 Chair: C. Hendrix BRWG: A. Minnis Sites: MRC, Botha s Hill; Bronx-Lebanon, NYC; CWRU, Cleveland; MU-JHU, Kampala; MWRI, Pittsburgh; UAB, Birmingham MRC, Umkomaas NIH/DAIDS FHI 360 SCHARP MTN core and Network Lab VOICE-C Chairs: J. Stadler; A. van der Straten Wits RHI: S.Seoka, F.Mathebula, B. Magazi FHI 360: K. Schwartz, K. Richards, R. White RTI/WGHI: E. Montgomery, M. Hartmann, H. Cheng, N. Laborde, E. Luecke MTN Core: NIH/DAIDS: VOICE-D Chair/co-chairs: A. van der Straten E. Montgomery, B. Mensch Sites: MRC; UZ-UCSF; MU-JHU. DTHF: Z. Duby, T. Bennie FHI 360: L. Levy, K. Alston RTI/WGHI: M. Hartmann; H. Cheng MTN Core NIH/DAIDS/NIMH ASPIRE Chair/co-chair: J. Baeten, T.Palanee Sites: MRC; ethekwini, UCT, Wits RHI, UZ-UCSF; MU-JHU, UNC-Lilongwe, JHU-Blantyre DTHF: Z. Duby, T. Bennie FHI 360: K. Schwartz, A. Mayo BRWG/Qual team: B. Mensch, A. van der Straten, E.Montgomery MTN Core NIH/DAIDS/NIMH 24

25 THANKS! 25