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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Pre-exposure Prophylaxis; HIV Infections

Treatments: Behavioral: Food vouchers; Behavioral: Case management; Behavioral: Community-based PrEP pickup points; Behavioral: PrEP support buddy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06274060

R01MH121161 (U.S. NIH Grant/Contract)

135399

IRB00012628 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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304 participants in 16 patient groups

Standard of care

No Intervention group

Description:

The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.

Case management

Experimental group

Description:

Participants will receive case management layered on existing standard of care.

Treatment:

Behavioral: Case management

Food vouchers

Experimental group

Description:

Participants will receive food vouchers layered on existing standard of care.

Treatment:

Behavioral: Food vouchers

PrEP support buddy

Experimental group

Description:

Participants will receive the PrEP support buddy intervention layered on existing standard of care.

Treatment:

Behavioral: PrEP support buddy

Community-based PrEP pickup points

Experimental group

Description:

Participants will receive the community-based PrEP pickup point intervention layered on existing standard of care.

Treatment:

Behavioral: Community-based PrEP pickup points

PrEP support buddy + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Community-based PrEP pickup points

Food vouchers + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: Community-based PrEP pickup points

Behavioral: Food vouchers

Food vouchers + PrEP support buddy

Experimental group

Description:

Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Food vouchers

Case management + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: Community-based PrEP pickup points

Behavioral: Case management

Case management + PrEP support buddy

Experimental group

Description:

Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Case management

Case management + Food vouchers

Experimental group

Description:

Participants in this arm will receive both the case management and food voucher interventions in combination.

Treatment:

Behavioral: Food vouchers

Behavioral: Case management

Food voucher + PrEP support buddy + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Community-based PrEP pickup points

Behavioral: Food vouchers

Case management + PrEP support buddy + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Community-based PrEP pickup points

Behavioral: Case management

Case management + Food vouchers + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: Community-based PrEP pickup points

Behavioral: Food vouchers

Behavioral: Case management

Case management + Food vouchers + PrEP support buddy

Experimental group

Description:

Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Food vouchers

Behavioral: Case management

Case management + Food vouchers + PrEP support buddy + Community-based PrEP pickup points

Experimental group

Description:

Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.

Treatment:

Behavioral: PrEP support buddy

Behavioral: Community-based PrEP pickup points

Behavioral: Food vouchers

Behavioral: Case management