Participant Motivation for Enrolling and Continuing in the FEM-PrEP HIV Prevention Clinical Trial

Christina Wong, Caleb Parker, Khatija Ahmed, Kawango Agot, Joseph Skhosana, Jacob Odhiambo, Shumani Makatu, Ansley Lemons,

Monique Mueller, Lut Van Damme and Amy Corneli for the FEM-PrEP Study GroupIAS 2013

Kuala Lumpur, Malaysia3 July 2013

FEM-PrEP Clinical Trial

• Design: Phase III, randomized, double-blind, placebo-controlled trial to assess the effectiveness and safety of TDF/FTC in preventing HIV acquisition in women ages 18 to 35 at higher HIV risk

• Sites: Bondo, Kenya; Bloemfontein and Pretoria, South Africa; Arusha, Tanzania

• Product Regimen: Once-daily TDF/FTC or placebo use for 52 weeks

• Enrollment/Retention: 2,120 women enrolled; 82% completed study (Van Damme, NEJM, 2012)

• Primary effectiveness result: Adherence too low to assess the efficacy of TDF/FTC as a daily, oral PrEP regimen in the study population

Embedded Qualitative Research

• Method: Quarterly semi-structured interviews (SSIs) were conducted with a 5% random sample of FEM-PrEP participants

• Sites: Bondo and Pretoria

• Topics and sample size: SSIs explored reasons for why participants -- – Enrolled in FEM-PrEP (n=92; Bondo=51; Pretoria=41) – Continued in FEM-PrEP (n=87; Bondo=49; Pretoria=38)

• Analysis: Qualitative thematic analysis

Reasons for Enrolling and Continuing in FEM-PrEP

• Personal benefits

• Altruism

• Non-motivator response

Reasons for Enrolling and Continuing in FEM-PrEP

30% 31%

64%

49%

11%

29%

0%

10%

20%

30%

40%

50%

60%

70%

Enrolling (n=92) Continuing (n=87)

Personal Benefits

Altruism

Non-MotivatorResponse

Personal Benefits – HIV Testing (1)

• 32% said for enrolling and 18% for continuing

• Participants:

– Felt they might have HIV so wanted HIV test

– Liked having an HIV test every month

– Expressed reassurance; said happy or relieved to learn their status each month

– Felt it more convenient being tested at study clinic than elsewhere

Personal Benefits – HIV Testing (2)

“I decided to join the clinical trial because I had been tested for HIV a long time back and now I wanted to know my HIV status.”

(Bondo participant)

“I feel comfortable knowing my status. So, every time I come here, the reason is that I wanted to get tested and know my status.”

(Pretoria participant)

Personal Benefits – Hoping to Remain HIV Negative (1)

• 25% said for enrolling and 13% for continuing

• Participants described their belief that the trial provided the potential to stay negative through receiving:

– Education and counseling on HIV prevention

– Condoms

– Study product

Personal Benefits – Hoping to Remain HIV Negative (2)

“What really made me join this study is that I saw that I will get different teachings…

The first time I came, the education I was given, my heart just liked it. I saw that I should just continue

being in this research because it’s something that is going to help my life.” (Bondo participant)

Personal Benefits – Disease Testing and Treatment (1)

• 22% said for enrolling and 9% for continuing

• Participants:– Thought or knew they had an illness and wanted

free medical support

– Wanted access to basic medical tests

– Interested in knowing more about other diseases such as cancers, STIs, TB, malaria

Personal Benefits – Disease Testing and Treatment (2)

“When you are not in a study, you cannot just go to a clinic and say ‘I am going to test for HIV and all these tests.’ You can’t just take your money and go to the doctor

to check yourself up. You see here at Setshaba, I get a lot of stuff. They start with pregnancy test, HIV, and they don’t just

check AIDS only, they check the whole body so I get to know about my life,

they even check my womb, everything.” (Pretoria participant)

Personal Benefits

• Few participants mentioned reimbursement: 2% said for enrolling and 2% for continuing

“To be honest, I like the R150.” (Pretoria participant)

Altruism

• 30% said for enrolling and 31% for continuing• Participants said they wanted to contribute to finding

an HIV prevention method, if it is determined the study product works– Participant knew someone who has HIV or died from

HIV, and wants to help prevent this disease– Wanted to help women in particular– Wanted to help her children in the future

Altruism

“If I have come and have not continued in the research, then I have done a meaningless job.

But, if I continue, then I have helped many people.” (Bondo participant)

"It's because I care. Meaning I care about this HIV thing. Meaning I want to see as years go by a cure being found for HIV, because many people die from HIV and AIDS.

I've lost many family members because of this disease. So I care. I want to see at the end, something be found

that can be able to cure or to prevent this disease." (Pretoria participant)

Conclusions

• The direct benefits offered by the trial appear to be a strong motivator for reasons participants enroll and continue their participation – Includes on-going HIV testing, counseling, and

healthcare services • Findings are similar to reasons reported in microbicide

trials1 but differ from HIV vaccine studies2,3

• As a field, we should discuss how to better incorporate participant reasons for trial participation into trial design

1Woodsong, AIDS Behav, 2011; 2Buchbinder, JAIDS, 2004; 3Pitisuttithum, Vaccine, 2010

Study Participants

Funders: U.S. Agency for International Development (USAID) and the Bill & Melinda Gates Foundation (preparatory work)

Study sites:Pretoria — Setshaba Research Centre: Khatija Ahmed, Mookho Malahleha, Malebo Ratlhagana, Shumani Makatu, Joseph Short Skhosana, Modie Constance Monedi, Elizabeth (Thupi) Rammutla, Fulufhelo Neluheni, Ulender Nzimande, Madibeletsa Mohale, Ross Malamatso, Ellen Modibane, Muriel Maria Lubethe, Refilwe Ireen Raliphaswa, Josephine Lindiwe Masemola, Steven Nicodemus Maubane, Kunene Penuel Gavin, Dimakatso Molete.

Bondo — Impact Research & Development Organization: Kawango Agot, Fred Owino, Jacob Odhiambo, Walter Agingu, Paul Omullo, Jesse Asewe, Billy Singh, Juma Juma, David Odhiambo, Lennah Oluoch, Lilian Ouma, Sheila Koloo, Dominic Akowo, Rose Odero, Thomas Odhiambo, Carolyne Otieno, Josephine Hagoi, Mary Adhiambo, Kezia Ogada.

Bloemfontein — JOSHA Research: Johan Lombaard, Ilse Reblin, Makanda Mankalimeng, Gustav Venter, Phumzile Siguntu

Arusha — Kilimanjaro Christian Medical Center: Saidi Kapiga, Rachel Manongi, Temu Lucky, John Gardner Gaddiel,

Martha Masaki

Laboratories:Prince Leopold Institute of Tropical Medicine (ITM) –Central Lab: Katrien Fransen, Tania Crucitti, Irith De Baetselier, Said Abdellati

Gladstone Institute of Virology and Immunology, University of California, San Francisco: Robert Grant, Patricia Dechefereux

UNC Chapel Hill, School of Medicine: Angela Kashuba

Collaborating partners:SCT Consulting: Savi Chetty-Tulsee, Tharnija Lalbahadur

Gilead Sciences, Inc. (study product): James F. Rooney

FHI 360: Lut Van Damme, Amy Corneli, Ward Cates, Jen Deese, Laneta Dorflinger, Jennifer Headley, Janet Kariuki, Haddie Kiernan, Stella Kirkendale, Michele Lanham, Ansley Lemons, Yun-Rong Ma, Justin Mandala, Timothy Mastro, Kevin McKenna, Monique Mueller, Sarah Mullins, Kavita Nanda, Zablon Omungo, Caleb Parker, Brian Perry, Lisa Saylor, Douglas Taylor, Amanda Troxler, Valentine Veena, Lalitha Venkatasubramanian, Meng Wang, Christina Wong.

FEM-PrEP Study Acknowledgments

See other FEM-PrEP presentations at IAS:

• Behavioral and Social Risk Characteristics of the FEM-PrEP Study Population (TUPE385)

• The Association Between Risk Perception and Adherence in the FEM-PrEP Clinical Trial (M0LBPE28)

• FEM-PrEP Strategic Recruitment Approach to Identify and Recruit Women at Higher Risk of HIV (TUPE372)

• Risk Perception and HIV Worry among Seroconverters in the FEM-PrEP Clinical Trial (TUPE386)