Clinical trial NCT06274060: Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa
Official title: Optimizing PrEP Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa: Phase 2b
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-exposure Prophylaxis
HIV Infections
Keywords: PrEP
HIV prevention
Adolescent girls and young women
Female sex workers
South Africa
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: TB HIV Care
name: Unity Health Toronto
name: National Institute of Mental Health (NIMH)
First posted: 2024-02-23
Enrollment: 304
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP persistence at 7 months after PrEP initiation
timeFrame: Month 7
measure: PrEP adherence at 7 months after PrEP initiation among all trial participants
timeFrame: Month 7
Secondary outcomes:
measure: PrEP persistence at 1 month after PrEP initiation
timeFrame: Month 1
measure: PrEP persistence at 4 months after PrEP initiation
timeFrame: Month 4
measure: PrEP persistence at 13 months after PrEP initiation
timeFrame: Month 13
measure: PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples
timeFrame: Month 7
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: TB HIV Care
state: KwaZulu Natal
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Sheree Schwartz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: TB HIV Care
name: Harry Hausler, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: