1. PrEP experiences among South African women in the HPTN067 (ADAPT) study: Healthy paranoia (skepticism), Ubuntu, champions and challenges to resolving PrEP dissonance The ADAPT Study Alternative Dosing to Augment PrEP Table Taking K Rivet Amico, PhD University of Michigan School of Public Health Department of Health Behavior and Health Education On behalf of the ADAPT Study Team

2. Adherence in PrEP RCTs with women in sub- Saharan Africa had mixed results –Some with very low product use by drug levels High rates of self-reported product use Subsequent work highlights dynamic facilitators and barriers –Several of which relate to context of RCT and use of drug of unknown efficacy Background Corneli et al., PLOS ONE 2015; Corneli et al., JAIDS 2015 Van der Straten et al., JAIS 2014; Van der Straten et al., PLOS ONE 2014 ADAPT…Experiences with open-label PrEP, provided in context of explicit efforts to minimize over-reporting

3. Average age 26, range 18-52 On self-administered PrEP for 24 weeks Qualitative data collected within 3-months of final study visit Invited to participate in FG or IDI in two waves (first and last half of project) Mixed convenience (FG) and targeted (IDIs) sampling Themes identified with framework analysis Methods 179 women participants 60 qualitative participants 2 Daily arm 42 FG participants 2 Time-driven arm 2 Event-driven arm 6 Daily arm 18 IDI participants 6 Time-driven arm 6 Event-driven arm

4. Results – THEMES [Poster #TUPEC515] Facilitators of PrEP use Challenges to PrEP use Facilitators of participation Erosion of engagement

5. Results – THEMES High value on reciprocity to community (Ubuntu) Healthy Skepticism (self, community) –Fears/concerns about PrEP provided by study –Fears/concerns about integrity/trustworthiness of trial/procedures –Influence of community, important others, and fellow participants on amplifying concerns Variable approaches to product use –Active avoidance –Champions

6. Developed a framework that integrates approach to study-provided PrEP in the context of the person, community, and study. Results – Model/Framework

7. Study Provided PrEP Use Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Approach to Study-Provided PrEP

8. Context Community-Participant-StudyDynamic Community-Participant-StudyDynamic Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Value of social and personal resources afforded through participationValue of social and personal resources afforded through participation Social-Political History with biomedical research and medical institutionsSocial-Political History with biomedical research and medical institutions Identity attributes as participant or product user (internally, to important others, in the community)Identity attributes as participant or product user (internally, to important others, in the community) Cultural world view emphasizing reciprocityCultural world view emphasizing reciprocity Product attributes Regimen Burden, Ease of use, Match to contextProduct attributes Regimen Burden, Ease of use, Match to context

9. Dynamics Community-Participant-StudyDynamic Community-Participant-StudyDynamic Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Dynamics – Different ways people negotiate tensions and synergies between community, self, and study/product Produce different approaches to study provided PrEP Have unique implications for intervention Depends heavily on alignment with study

10. Model of Mutuality Community-Participant-StudyDynamic Community-Participant-StudyDynamic Uncertainty Alignment Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Distrust Mutuality Model identifies 4 unique dynamics ranging from distrust to mutuality -Explain unique characteristics of each dynamic -Associated approach to PrEP -A excerpt highlighting an important aspect of the dynamic

11. Model of Mutuality-Distrust Community-Participant-StudyDynamic Community-Participant-StudyDynamic Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Distrust Rejection of product safety, integrity of study, and potential reciprocity to community Intentional Avoidance of use of PrEP (and disclosure) “… I will never drink these pills because I don't trust them…” -T IDI

12. Model of Mutuality- Uncertainty Community-Participant-StudyDynamic Community-Participant-StudyDynamic Uncertainty Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Distrust Cautious exploration- not yet sure either way Variable persistence with PrEP “…I was getting confused and pressured because I did not know whether to continue take tablets or not.”-- D IDI

13. Model of Mutuality- Alignment Community-Participant-StudyDynamic Community-Participant-StudyDynamic Uncertainty Alignment Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Distrust Provisional acceptance- committed to try Good persistence/Variable adherence to PrEP “… I wouldn’t do any of that [not take the tablets] because I want to see if these pills really, really work” -- T FG

14. Model of Mutuality - Mutuality Community-Participant-StudyDynamic Community-Participant-StudyDynamic Uncertainty Alignment Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Distrust Mutuality Ownership/Advocacy- Champions Good persistence/Good adherence to PrEP “… and I said: “Look here, ask me. And don’t you dare say I have HIV, telling everyone in this shop. We are doing research here… to see whether the pills can protect someone from HIV.” -- E FG

15. Model of Mutuality Community-Participant-StudyDynamic Community-Participant-StudyDynamic Uncertainty Alignment Intentional Avoidance Variable Persistence Variable Adherence (Execution) High Adherence High Persistence Contexts Approach to Study-Provided PrEP Distrust Mutuality SUPPORT STRATEGIES MUST REFLECT CURRENT DYNAMIC EXAMPLES 1:1 targeting of barriers to execution adherence not relevant in DISTRUST and could promote staying in that dynamic Messaging on importance of adherence may be disempowering in the MUTUALITY dynamic

16. Recommendations Do not assume participants enter a study ‘neutral’ in beliefs or trust of study Products (and studies) need to prove themselves as valuable, safe and trustworthy –Need creative, engaging community focused ways to integrate community into research- CBPR practices promote exploration and decision making around product use enhance trust in trials and reciprocity for contributions

17. Limitations Model based on qualitative discourse in a specific cohort. Cannot assume generalizability to other groups or “real world” PrEP use. Model is a proposed framework –Requires validation and measures of mutuality dynamics

18. Conclusions The proposed mutuality model offers a framework for understanding intersections of community, participant and study –Consistent with findings in other work in this area –Synergistic with models of community participatory and action based research Product-use and PrEP-use occurs in context where safety and beliefs about benefits to self and community are necessary preliminary conditions for optimal uptake and use to have a chance to occur

19. The HIV Prevention Trials Network is sponsored by the National Institute of Allergy and Infectious Diseases, the National Institute of Mental Health, and the National Institute on Drug Abuse, all components of the U.S. National Institutes of Health. ACKNOWLEDGEMENTS Gladstone Institute of Virology and Immunology

20. Cape Town Qualitative Team Melissa Wallace Linda-Gail Bekker Surita Roux Millicent Atujuna Elaine Sebastian Thank you