The overarching goals of this proposed revision are to examine pre-exposure prophylaxis (PrEP) utilization and the potential for PrEP delivery strategies inclusive of peer support models to increase adherence and PrEP persistence among HIV-negative female sex workers (FSW) in Durban, South Africa. Despite demonstrated HIV acquisition risks, PrEP uptake among FSW has been inconsistent outside of demonstration projects and by 3 months 50-85% of FSW initiating PrEP have discontinued product use. The proposed study is embedded within TB HIV Care?s existing PEPFAR-funded PrEP delivery program for FSW and will adapt a case management support intervention to promote adherence to antiretroviral therapy (ART) among FSW living with HIV in Durban to the needs of HIV-negative FSW PrEP service users.
Specific Aim 1 : Characterize barriers and facilitators to PrEP reach and continuation among FSW in the existing program. Approach: (a) Quantitatively compare characteristics of FSW adopters and decliners using existing programmatic data. (b) Conduct in-depth interviews (IDIs) with FSW and key informants to explore facilitators and barriers to PrEP use, including 12 IDIs each with PrEP-eligible FSW not on PrEP, FSW who started PrEP but did not get past the 1-month mark and FSW who completed 1-month or more of PrEP. An additional 12 IDIs with key informants (venue managers, peer educators, PrEP referral team members, PrEP nurses) will be conducted to understand external messaging and pressures that may motivate or impede PrEP use.
Specific Aim 2 : Characterize indicators of the potential effectiveness and optimal implementation of an enhanced peer-based case management intervention among FSW initiating PrEP. Approach: Peer case management will be used to provide individualized peer support to FSW during the first 3 months of PrEP use. Thirty FSW will be enrolled in the 3-month pilot intervention. All FSW will receive a 30-day ?base? intervention (weekly face-to-face case management sessions) and may choose to receive ?enhanced? top-up components (phone calls, text messages, support group, PrEP delivery via case manager). Participant preferences for intensity of support, fidelity of intervention delivery, costs, PrEP continuation through 3-months and PrEP adherence measured through DBS collected at 1- and 3-months will be assessed.
Specific Aim 3 : Longitudinally evaluate the FSW PrEP experience and case-management intervention? including acceptability, perceived effectiveness at improving short-term PrEP continuation, and long-term maintenance. Approach: Serial IDIs with all PrEP case management participants will be conducted at initiation, 1- and 3-months to gain insights into the early PrEP decision-points and experiences with the peer case management approach, incorporating real-time feedback into the intervention. A focus group discussion (FGD) with case managers will provide additional insights into the potential for programmatic adoption and maintenance.

Public Health Relevance

This implementation science study utilizes the RE-AIM framework to examine pre-exposure prophylaxis (PrEP) reach and evaluate the potential for PrEP delivery strategies and peer support models to increase adherence and persistence among HIV-negative female sex workers (FSW) in Durban, South Africa. We aim to evaluate whether a case management intervention for FSW living with HIV on antiretroviral therapy can be adapted for HIV-negative FSW and intensified in the early months of PrEP delivery to promote PrEP adherence and sustained use. Furthermore, the study will explore barriers and facilitators to PrEP adoption and persistence ? with specific attention given to the first 3 months of PrEP uptake, a critical period to PrEP success.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
3R01NR016650-04S1
Application #
9874283
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Henry, Rebecca
Project Start
2016-09-26
Project End
2020-06-30
Budget Start
2019-07-01
Budget End
2020-06-30
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205