Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa

HIV Infections Clinical Trial

Official title:

Optimizing PrEP Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa: Phase 2b

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274060
• Other study ID #: 135399
• Secondary ID: R01MH121161IRB00
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Sheree Schwartz, PhD, MPH
• Phone: 4105029298
• Email: sschwartz[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.

Description:

The overall aim of this trial is to investigate which PrEP support strategies most effectively and efficiently optimize(s) PrEP persistence among female sex workers (FSW) and adolescent girls and youth women (AGYW) in South Africa. The trial will be implemented by TB HIV Care, a South African non-profit organization that provides direct HIV service delivery to FSW and AGYW across 10 districts in South Africa. The investigators plan to individually randomize 304 FSW and AGYW at the TB HIV Care site in uMgungundlovu, KwaZulu-Natal, to a fractional factorial trial, randomizing combinations of four separate strategies to support PrEP continuation. As fthe strategies are being tested, this results in 16 different intervention/study conditions, with one condition serving as a control where FSW and AGYW will receive the standard of care and no additional PrEP support. The other 15 conditions will be a combination of the standard of care alongside different PrEP delivery and support strategies implemented by TB HIV Care: case management, food vouchers, peer support buddies, and PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use and persistence, so that these services can be scaled up to other TB HIV Care sites. By utilizing the fractional factorial design in alignment the multiphase optimization strategy framework (MOST) the trial is feasible to conduct even with 16 arms, as the design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Initiated PrEP within the past 48 hours by the TB HIV Care PrEP programme in uMgungundlovu through the female sex worker (FSW) or adolescent girls and young women (AGYW) PrEP programme teams

Exclusion Criteria:

• Not eligible for PrEP

• Currently on PrEP, but initiated onto PrEP more than 48 hours previously

• Under 16 years of age if AGYW OR under 18 years of age if FSW

Related Conditions & MeSH terms

• HIV Infections
• Pre-exposure Prophylaxis

Intervention

Behavioral:
• Case management
Participants will receive case management delivered by a peer with PrEP experience/success for seven months, with the goal of improving self-efficacy to take PrEP. The intention of this intervention is to help participants to develop individualized strategies to address and overcome barriers to PrEP use, as well as develop disclosure strategies. This strategy includes weekly face-to-face support with the case manager for the first month of the trial, followed by monthly face-to-face support for the remainder of the trial follow up period. The strategy will also include client-initiated on-demand phone consultation with the case manager and mental health/substance use screening and referrals. Participants randomized to this strategy may also opt into daily timed PrEP pill-taking reminders via short message service (SMS).
• Food vouchers
Participants will be given food vouchers with a value of 200 South African Rand at the time of PrEP initiation and at 1- and 4-month standard of care visits at which clinical checkups and PrEP refills are provided. The goal of these vouchers is to improve participants' capacity to persist on PrEP. While PrEP can be taken without food, some experience increased side effects or prefer to take pills with food, making adherence difficult if they cannot afford food at times.
• PrEP support buddy
Participants will identify a person in their network (such as a friend, partner, parent) that they wish to support them in their PrEP usage, with the goal of improving participants' motivation and self-efficacy to persist on PrEP and providing social support to facilitate ongoing PrEP use. Support buddies selected by FSW and AGYW randomized to this intervention will receive a one-time training session on PrEP and support strategies as well as informational materials and text reminders to assist them in providing ongoing PrEP support.
• Community-based PrEP pickup points
Participants will be able to pick up PrEP from alternative pick-up points within the community that are convenient for them, with the goal of making PrEP more accessible to participants. Ten pickup points will be established at existing Hubs of Hope throughout the subdistricts served by the TB HIV Care programme. Hubs of Hope are based in the War Rooms within subdistricts, where the TB HIV Care programme operates, and serve as meeting places for service users to receive support searching for jobs, completing online courses, and other personal development activities to support a multi-sectoral approach to health. A TB HIV Care ambassador is based at each Hub of Hope to coordinate activities and provide support to service users. Participants who choose to use pick-up points will have the option of either completing an HIV self-test or testing with the on-site TB HIV Care staff to confirm HIV-negative status prior to receipt of PrEP refills.

Locations

Country	Name	City	State
South Africa	TB HIV Care	Pietermaritzburg	KwaZulu Natal

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Mental Health (NIMH), TB/HIV Care, Unity Health Toronto

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP persistence at 7 months after PrEP initiation	Proportion of trial participants who returned for their 7-month PrEP refill visit.	Month 7
Primary	PrEP adherence at 7 months after PrEP initiation among all trial participants	The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) =700 femtomoles per DBS sample. Among participants that do not return for DBS, the investigators will assume non-adherence and they will be included in this outcome.	Month 7
Secondary	PrEP persistence at 1 month after PrEP initiation	Proportion of trial participants who returned for their 1-month PrEP refill visit.	Month 1
Secondary	PrEP persistence at 4 months after PrEP initiation	Proportion of trial participants who returned for their 4-month PrEP refill visit.	Month 4
Secondary	PrEP persistence at 13 months after PrEP initiation	Proportion of trial participants who returned for their 13-month PrEP refill visit.	Month 13
Secondary	PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples	The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) =700 femtomoles per DBS sample. Those who do not return at 7-months or do not provide a DBS sample will be excluded from this analysis.	Month 7