MWOTAJI: Making Women's Options for HIV Prevention In Tanzania Accessible, and Joining in Implementation Science Capacity Building
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,818
- 试验地点
- 1
- 主要终点
- Effective use of PrEP
研究概览
简要总结
Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania. At 9 months, all sites converge to one pharmacy-based PrEP model and are randomly allocated to one of two cost sharing models to increase the program's potential for sustainability.
详细描述
This study will evaluate the effectiveness of pharmacy-based PrEP implementation for YW in the Lake Zone, Tanzania. Four models for pharmacy-based PrEP delivery will be evaluated and compared to pharmacies that do not provide any PrEP services for 9 months (phase I of the implementation study). The PrEP implementation models build on one another with each pharmacy-based PrEP model providing progressively expanded access to PrEP in pharmacies for YW.
All PrEP implementation models will be implemented alongside a girl-friendly loyalty program (Mwotaji Program) offering free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives.
Comparison: Standard facility based PrEP services to YW.
After 9 months (phase II), all pharmacies will implement the best performing PrEP model, based on findings from phase I. Moreover, all 50 pharmacies will implement cost-sharing. The investigators will assess acceptability, feasibility, and potential for sustainability of the pharmacy-based PrEP models. Two cost-sharing approaches will be randomized across the CRPS in a 3:2 ratio:
- Fee-for-service model: PrEP refills provided for 500 Tanzanian Shillings (TZS) each, a standard cash-based transaction for user fees, benchmarked with data from prior studies.
- Loyalty hybrid model: PrEP refills provided for free with any shop purchase or a fee of 500 TZS without a purchase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(Parent study: YW cohort study):
- •Female sex;
- •Age 18-24 at the baseline visit;
- •Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania with no known plans to move;
- •Interested in starting PrEP;
- •Access to a mobile phone (either own phone or borrowed phone); and
- •Eligible for PrEP based on Tanzania National PrEP Guidelines behavioral screening criteria
排除标准
- •Currently taking PrEP (refilled a PrEP prescription within the past 28 days at enrollment).
- •Inclusion Criteria (Sub-study: YW household survey):
- •Female sex;
- •Age 18-24; and
- •Living in one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania.
- •Exclusion Criteria (Sub-study: YW household survey): N/A
- •Inclusion Criteria (Study pharmacies):
- •Geographically located within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania;
- •Located within 4 km of at least 1 health facility that provides PrEP services and whose lab conducts creatinine and hepatitis B testing;
- •Has no planned extended closures over the next 24 months.
- •Exclusion Criteria (Study pharmacies): N/A
- •Inclusion Criteria (Sub-study: Pharmacy staff):
- •Pharmacy owners and staff affiliated with study pharmacies; and
- •≥18 years of age.
- •Exclusion Criteria (Sub-study: Pharmacy staff): N/A
- •Inclusion Criteria (Sub-study: Stakeholders):
- •Staff employed at referral health facilities within one of five study sites in Shinyanga, Geita or Kagera regions of Tanzania or local, regional, or national government officials;
- •≥18 years of age.
- •Exclusion Criteria (Sub-study: Stakeholders): N/A
研究组 & 干预措施
Model A: PrEP referrals
Model A: PrEP Referrals - Pharmacies in CRPS assigned to this implementation model will conduct behavioral screening for PrEP eligibility for young women (see Box 1, Section A). Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the CTC health facility for clinical screening, PrEP dispensation and required laboratory testing (i.e., HIV and creatinine testing, a component of clinical screening).
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW.
干预措施: Pharmacy-based PrEP services (Behavioral)
Model A: PrEP referrals
Model A: PrEP Referrals - Pharmacies in CRPS assigned to this implementation model will conduct behavioral screening for PrEP eligibility for young women (see Box 1, Section A). Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the CTC health facility for clinical screening, PrEP dispensation and required laboratory testing (i.e., HIV and creatinine testing, a component of clinical screening).
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW.
干预措施: Distribution of HIV self-test kits (Behavioral)
Model B: PrEP screening and PrEP refills
Model B: PrEP Refills - In addition to behavioral screening for PrEP eligibility for young women, pharmacies in CRPS assigned to this implementation model will offer PrEP refills to study participants. Pharmacies will first conduct the behavioral screening for PrEP eligibility for young women. Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the health facility CTC for PrEP dispensation, further clinical screening and required laboratory testing. Young women will then be able to return to the pharmacy to receive PrEP refills. Refill provision includes rescreening for PrEP eligibility at each visit (Box 1); repeat HIV testing is required at the CTC at Month 1 and then every three months thereafter.
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to YW.
干预措施: Pharmacy-based PrEP services (Behavioral)
Model B: PrEP screening and PrEP refills
Model B: PrEP Refills - In addition to behavioral screening for PrEP eligibility for young women, pharmacies in CRPS assigned to this implementation model will offer PrEP refills to study participants. Pharmacies will first conduct the behavioral screening for PrEP eligibility for young women. Young women who are determined to be eligible for PrEP based on the behavioral screening will be enrolled and referred to the health facility CTC for PrEP dispensation, further clinical screening and required laboratory testing. Young women will then be able to return to the pharmacy to receive PrEP refills. Refill provision includes rescreening for PrEP eligibility at each visit (Box 1); repeat HIV testing is required at the CTC at Month 1 and then every three months thereafter.
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to YW.
干预措施: Distribution of HIV self-test kits (Behavioral)
Model C: PrEP screening, PrEP refills, and PrEP initiation
Model C: PrEP Initiation - Pharmacies in CRPS assigned to this implementation model will offer PrEP initiation services for young women enrolled in the study. Pharmacies in CRPS assigned to this implementation model will first conduct the behavioral and clinical screenings and refer participants to the health facility lab for required laboratory testing. Participants who are HIV negative will return to the pharmacy for dispensation of 30 days of PrEP medication, adherence and side effects counseling, and scheduling a next appointment for a PrEP refill in 30 days.
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW.
干预措施: Pharmacy-based PrEP services (Behavioral)
Model C: PrEP screening, PrEP refills, and PrEP initiation
Model C: PrEP Initiation - Pharmacies in CRPS assigned to this implementation model will offer PrEP initiation services for young women enrolled in the study. Pharmacies in CRPS assigned to this implementation model will first conduct the behavioral and clinical screenings and refer participants to the health facility lab for required laboratory testing. Participants who are HIV negative will return to the pharmacy for dispensation of 30 days of PrEP medication, adherence and side effects counseling, and scheduling a next appointment for a PrEP refill in 30 days.
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji, which provides free sexual and reproductive health products including HIV self-test kits, pregnancy tests, and contraceptives to AGYW.
干预措施: Distribution of HIV self-test kits (Behavioral)
Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator
Model D: Peer Navigator - Pharmacies in CRPS assigned to this implementation model will offer to link young women utilizing PrEP services to a PrEP peer navigator. This is in addition to PrEP screening, PrEP initiation, and refill services for young women.
Peer navigators are current or former young female PrEP users (age 18 or older, not considered study participants) who are willing to provide periodic advice, guidance, and referrals to the health facility for study participants. The role of the peer navigator is to enhance the pharmacy's protocols for linkage to health facilities for various SRH services, antenatal care, long-acting reversible contraceptives, STI screening, and/or PrEP consultations (e.g., side effects, safely stopping PrEP). There will be a minimum of one and a maximum of three peer navigators assigned to support each pharmacy in this implementation model.
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji.
干预措施: Pharmacy-based PrEP services (Behavioral)
Model D: PrEP screening, PrEP refills, PrEP initiation, and linkage to a PrEP peer navigator
Model D: Peer Navigator - Pharmacies in CRPS assigned to this implementation model will offer to link young women utilizing PrEP services to a PrEP peer navigator. This is in addition to PrEP screening, PrEP initiation, and refill services for young women.
Peer navigators are current or former young female PrEP users (age 18 or older, not considered study participants) who are willing to provide periodic advice, guidance, and referrals to the health facility for study participants. The role of the peer navigator is to enhance the pharmacy's protocols for linkage to health facilities for various SRH services, antenatal care, long-acting reversible contraceptives, STI screening, and/or PrEP consultations (e.g., side effects, safely stopping PrEP). There will be a minimum of one and a maximum of three peer navigators assigned to support each pharmacy in this implementation model.
Pharmacies will also implement the girl-friendly loyalty program, Mwotaji.
干预措施: Distribution of HIV self-test kits (Behavioral)
Comparison
Comparison: No PrEP services will be provided in pharmacies during phase I of the study; young women will receive PrEP from health facilities per the current standard of care. If young women go to a pharmacy and express interest in PrEP, they will be referred to the health facility for more information and PrEP access. In phase II of the study (cost-sharing), pharmacies assigned to the comparison group will provide pharmacy-based PrEP services corresponding to the best performing PrEP model determined at the end of phase I.
干预措施: Distribution of HIV self-test kits (Behavioral)
结局指标
主要结局
Effective use of PrEP
时间窗: 9 months
YW received a PrEP refill for all months during which an YW reports being at risk for HIV and PrEP eligible over the 9-month study period (among PrEP initiates only)
Persistent use of PrEP
时间窗: 9 months
YW picked up all scheduled PrEP refills without a delay of \>28 days over the 9- month study period (among PrEP initiates only)
Reach of PrEP implementation model
时间窗: 9 months
Heard of pharmacy-based PrEP services (including screening, referrals, refills, or initiation)
次要结局
- Acceptability of PrEP implementation model(9 months, 15 months)
- Fidelity to PrEP implementation model(9 months, 15 months)
- Feasibility of PrEP implementation model(9 months, 15 months)
- Adoption of PrEP implementation model(9 months, 15 months)
研究者
Mackfallen Giliadi Anasel
Head of Department of Health Systems Management and Centre of Excellence in Health Monitoring and Evaluation, Mzumbe University
Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation