Optimizing PrEP Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa: Phase 2b
概览
- 阶段
- 不适用
- 干预措施
- Case management
- 疾病 / 适应症
- Pre-exposure Prophylaxis
- 发起方
- Johns Hopkins Bloomberg School of Public Health
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- PrEP persistence at 7 months after PrEP initiation
- 状态
- 已完成
- 最后更新
- 昨天
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Case management + Food vouchers + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
干预措施: Case management
Case management + Food vouchers + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
干预措施: Food vouchers
Case management + Food vouchers + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
Case management + Food vouchers + PrEP support buddy
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
干预措施: Case management
Case management + Food vouchers + PrEP support buddy
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
干预措施: Food vouchers
Case management + Food vouchers + PrEP support buddy
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
干预措施: PrEP support buddy
Case management + Food vouchers + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Case management
Case management + Food vouchers + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Food vouchers
Case management + Food vouchers + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: PrEP support buddy
Case management + Food vouchers + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
Standard of care
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
Participants will receive case management layered on existing standard of care.
干预措施: Case management
Food vouchers
Participants will receive food vouchers layered on existing standard of care.
干预措施: Food vouchers
PrEP support buddy
Participants will receive the PrEP support buddy intervention layered on existing standard of care.
干预措施: PrEP support buddy
Community-based PrEP pickup points
Participants will receive the community-based PrEP pickup point intervention layered on existing standard of care.
干预措施: Community-based PrEP pickup points
PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
干预措施: PrEP support buddy
PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
Food vouchers + Community-based PrEP pickup points
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
干预措施: Food vouchers
Food vouchers + Community-based PrEP pickup points
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
Food vouchers + PrEP support buddy
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
干预措施: Food vouchers
Food vouchers + PrEP support buddy
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
干预措施: PrEP support buddy
Case management + Community-based PrEP pickup points
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
干预措施: Case management
Case management + Community-based PrEP pickup points
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
Case management + PrEP support buddy
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
干预措施: Case management
Case management + PrEP support buddy
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
干预措施: PrEP support buddy
Case management + Food vouchers
Participants in this arm will receive both the case management and food voucher interventions in combination.
干预措施: Case management
Case management + Food vouchers
Participants in this arm will receive both the case management and food voucher interventions in combination.
干预措施: Food vouchers
Food voucher + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Food vouchers
Food voucher + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: PrEP support buddy
Food voucher + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
Case management + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Case management
Case management + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: PrEP support buddy
Case management + PrEP support buddy + Community-based PrEP pickup points
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
干预措施: Community-based PrEP pickup points
结局指标
主要结局
PrEP persistence at 7 months after PrEP initiation
时间窗: 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
时间窗: 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.
次要结局
- PrEP persistence at 13 months after PrEP initiation(Month 13)
- PrEP persistence at 1 month after PrEP initiation(Month 1)
- PrEP persistence at 4 months after PrEP initiation(Month 4)
- PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples(Month 7)