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

Not Applicable

Completed

• Conditions: HIV Infections; Pre-exposure Prophylaxis

• Registration Number: NCT06274060
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-23
• Study Start: 2024-04-16
• Status Verified: 2025-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
PrEP persistence at 7 months after PrEP initiation	Month 7	Proportion of trial participants who returned for their 7-month PrEP refill visit.
PrEP adherence at 7 months after PrEP initiation among all trial participants	Month 7	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.

Secondary Outcome Measures

Name	Time	Method
PrEP persistence at 13 months after PrEP initiation	Month 13	Proportion of trial participants who returned for their 13-month PrEP refill visit.
PrEP persistence at 1 month after PrEP initiation	Month 1	Proportion of trial participants who returned for their 1-month PrEP refill visit.
PrEP persistence at 4 months after PrEP initiation	Month 4	Proportion of trial participants who returned for their 4-month PrEP refill visit.
PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples	Month 7	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.

Trial Locations

Locations (1)

TB HIV Care; 🇿🇦 Pietermaritzburg, KwaZulu Natal, South Africa