WHATS LOVE GOT TO DO WITH IT The

WHAT’S LOVE GOT TO DO WITH IT? The Role of Partnered Relationships In Adherence to Pr. EP Norma C. Ware, Ph. D Harvard Medical School

Study Within a Study…Within a Study Partners Pr. EP Adheren ce Study Qualitativ e Study

“Parent” Investigations Partners Pr. EP Clinical Trial: ongoing, Phase III, double-blind, three-arm trial evaluating safety and effectiveness of once-daily oral Pr. EP for HIVnegative individuals in stable, heterosexual serodiscordant couples (Connie L. Celum, MD, PI) Adherence Measurement Study: adds unannounced home-based pill counts and MEMS adherence measurement to Trial’s clinic-based pill counts to assess adherence in a subsample Partners Trial participants (David R. Bangsberg, MD, MPH, PI)

Data Collection Sites 9 Sites: Uganda and Kenya 3 sites: Uganda Single Site: Rural Southwes t Uganda

Kabwohe Clinical Research Centre

Qualitative Data Collection § In-depth interviews with HIV-negative individuals taking Pr. EP (or placebo) and with HIV-positive partners § § Focus on experiences of Pr. EP adherence Carried out by Ugandan interviewers trained in qualitative methodology

Characteristics of Participants § Number: 47 § Gender: § § § Women: 47% (N=21) Men: 53% (N=26) Mean age at enrollment in Partners Trial: 37 Mean reported length of time in relationship with partner at enrollment in Partners Trial: 10. 1 years Children with Partners: 81%

Definition of Stable Relationship § § § Marriage or cohabitation with no plans to separate (at enrollment) Sexually active in the relationship Children or intention to have children together

Theory: The Role of Partnered Relationships in Pr. EP Adherence

Excellent Adherence to Date § Median Adherence Rates at Partners Trial Adherence Study Sites Measurement Approach Median Adherence Clinic –based Pill Counts 99. 6% (IQR 96. 1 -100. 9) MEMS 101. 9% (IQR 97. 4 -104. 7) Unannounced Pill Counts 99. 1% (IQR 97. 2 -100. 0) Courtesy of Jessica Haberer, MD

Comparisons Study Populatio n Intervention Adherence i. Pr. Ex MSM Daily Oral Pr. EP Median 89 -95% by pill count CAPRISA Heterosexua Coitally dependent l topical gel Women Median 60% by self-report

Purpose of Theory Explain excellent adherence rates being observed in the Partners Pr. EP Clinical Trial Adherence Measurement Study

Initial Observation § Revelation of serodiscordance is profoundly de-stabilizing to partnered relationships § § Suggestion of infidelity Stigma Premature death of HIV+ spouse Threat to possibility of having (more) children

Serodiscordance = Disrupted Lives § § § Discord in the relationship (disappointment, suspicion, resentment drives people apart) Husbands/children abandoned, wives thrown out Separation or divorce

The Discordance Dilemma “I feel stuck. I love my wife. I want to have sex. I don’t like condoms. I don’t want to get infected, either. . . It’s not easy. It’s difficult. It’s a dilemma. ” (QLA 018)

Pr. EP § A medication that may protect against HIV transmission § In a sexual relationship § Without condoms (if it works) § Restore the prospect of having children

Meaning of Pr. EP § Hope of Resolving Discordance Dilemma § § Pr. EP as alternative to relationship breakup A way for HIV- negative individuals to avoid HIV infection, and stay with their HIV -positive partners

The “Hope” of Pr. EP: “If it wasn’t for this research, I wouldn’t be with my wife after discovering she is HIV+. All my hopes are in this research, because I don’t have any other protection. I can’t say I will keep using condoms all the time… When this research ends, I will know whether the drugs work or not. I will know whether the drugs can prevent HIV or not and then see whether to go ahead and

Pr. EP Doesn’t Mean “Happily Ever After” § Continuing discord between partners stemming from lack of trust

Suspicion of “Sinister Motives”: “Whenever he [gets home late], I get so angry suspecting he was with other women. Because he knows I am negative, I start suspecting he has a sinister motive of wanting to infect me. ” (QLA 015)

Suspicion Demoralization Lapses Adherence “So when he comes back at 9: 30 p. m. , before I take my medicine, I become so angry [and] I think, ‘it’s useless to keep taking this medicine. ’ Because of that, I decided to leave it. ” (QLA 015)

Individual Adherence Strategies § Picking the best dosing time § Using Reminders § § § Radio programs Clocks Phone alarms

Family Supports § § Reminders Making pill-taking more convenient (bringing water, porridge)

Partners Trial & Adherence Study Supports § § § Ongoing supportive counseling to adjust to serodiscordance, resolve relationship problems, promote adherence and retention Home visits are also experienced as supportive Adherence Study intervention for low adherers

Non-Relationship Barriers to Adherence § Obstacles to taking pills § § Disclosure: risk of being thought to be HIV+ Side effects: nausea, weakness, dizziness Pill Burden: size Difficulties of keeping clinic appointments: distance, expense

Ongoing Supportive Counseling: “I wanted to chase away my first wife, actually divorce her. But when I sat with the counselors, they advised me and gave me some options, and my heart settled… The counselors care about us so much. ” (QLA 008) “[I was not taking drugs] for like three months. When I went back to the clinic, they again educated me, and I saw for sure that I had to resume taking my

Excellent Pr. EP Adherence Explained by Motive to Preserve Relationship The Discordance Dilemma Tension between desires for good health and partnered relationship Partnered Relationship Benefit from Pr. EP requires adherence Adherence confers sense of protection Pr. EP offers hope for resolving dilemma by avoiding HIV infection while remaining in relationship

Additional Factors that Shape Pr. EP Adherence The Discordance Dilemma Individual Adherenc e Strategies Adherence Barriers Tension between good health & partnered relationshi p Study Supports Partnered Relationship Good Adherence “Hope of Pr. EP” to resolve discordance dilemma Family Support

Limitations A single site in rural southwest Uganda Research context: dynamics of adherence in “real-world” may be different Data generate, not confirm, theory— initial insights and a “starting point for

Conclusion: The Role of Relationships § The hope of preserving good health while staying in a serodiscordant relationship through Pr. EP explains excellent adherence observed in the Partners Pr. EP Trial Adherence Measurement Study to date

Acknowledgements § § § § § David R. Bangsberg, MD, MPH Connie Celum, MD MPH Monique A. Wyatt Jessica E. Haberer, MD, MS Jared Baeten, MD, Ph. D Elioda Tumwesigye, MBCh. B, MS The Uganda Qualitative Research Team Qualitative Study Participants The Bill and Melinda Gates Foundation