Introduction
Methods
Study period | ||||
---|---|---|---|---|
Enrollment | Baseline | Post-allocation | ||
Timepoint | 0 months Providers | 3 months Providers | 3 months Clients | |
Enrollment: | ||||
Eligibility screena | X | X | ||
Informed consent | X | X | ||
Peer provider randomization | X | |||
Peer providers refer peer clientsb | X | |||
Interventions: | ||||
Formal peer PrEP referral + HIVST delivery | X | |||
Informal peer PrEP referral | X | |||
Assessments: | ||||
Baseline characteristicsc | X | X | ||
Primary and secondary outcomesd | X | X |
Study design and setting
Study participants
Participant type | Eligibility | Ineligibility | Recruitment |
---|---|---|---|
Peer providers (n = 80) | • ≥ 16 to 24 years olda • Female • Must have refilled or initiated PrEP (i.e., been dispensed PrEP) • Can identify four peers at HIV risk who could benefit from PrEP • Not currently enrolled in an HIV study • Able and willing to be randomized, participate in research activities, and provide informed consent | • Not ≥ 16 to 24 years olda • Male • Have not used PrEP • Cannot identify four peers at HIV risk who could benefit from PrEP • Unable or willing to be randomized, participate in research activities, and provide informed consent • Currently enrolled in an HIV study • Illiterate | • Recruit participants from HIV clinics where PrEP is available using strategies established by the research team (e.g., workshops for healthcare workers) |
Peer clients (n = 320 max) | • ≥ 16 to 24 years olda • Female • Referred by peer provider to PrEP services (formally or informally) • Able and willing to participate in research activities and provide informed consent | • Not ≥ 16 to 24 years olda • Male • Not referred by peer provider to PrEP services (formally or informally) • Not able or willing to participate in research activities and provide informed consent | • Peer providers will recruit peer clients • At the point of recruitment, peer clients will call research staff to provide their contact information for follow-up. If peer clients call the study staff, both the peer client and provider will receive 50 KES via mobile money |
Study procedures
Randomization
Intervention: Formal peer PrEP referral + HIVST delivery
Control: Informal peer PrEP referral
Study visits
Data collection
Survey section | Description | Baseline | Follow-up | |
---|---|---|---|---|
Providers | Providers | Clients | ||
Demographics | Age, education, marital status, relationship status, age of sexual partner, monthly income | X | X | |
Sexual behaviors | Sexual intercourse frequency, condom usage, number of sexual partners, HIV status of partner, STI history, contraception usage, PEP usage, transactional sex, HIV testing history | X | X | X |
Depression | Patient Health Questionnaire-2 (PHQ-2) scale | X | X | X |
Relationship with peers | Sexual behavior discussion with peers, and peers' risk of HIV infection. Additionally, we will use the Multidimensional Scale of Perceived Social Support (MSPSS) scale | X | X | X |
HIV risk perception, PrEP use, knowledge, and stigma | Perception of HIV risk in the next 3 months. PrEP usage history, PrEP initiation, adherence/retention, continuation, escorted peers to PrEP services, intervention materials delivered to peers. General PrEP knowledge. PrEP stigma based on the Modified Perceived Stigma Scale Kaai 2012 | X | X | X |
Self-efficacy and experience of Peer PrEP referral + HIVST model | Provider: set of questions asking provider's abilities to deliver the PrEP referral + HIVST model, and their experiences asking after delivering the model. Client: set of questions asking the client’s experiences on receiving the PrEP referral + HIVST model | X | X | X |
Acceptability, appropriateness, and feasibility of Peer PrEP referral + HIVST model | Acceptability: Theoretical Framework of Acceptability (TFA). Appropriateness, and feasibility: Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) scales | X | X | X |
Social harms | Gender-based violence and harms related to online PrEP referral + HIVST model | X | X | X |
Outcomes
Outcomes | Definition | Denominator | Reported by | Timing |
---|---|---|---|---|
Primary and secondary | ||||
PrEP initiation (primary) | % peer clients that went to a clinic and were dispensed PrEP | Peer clients referred | Peer providersa | Month 3 |
Recent HIV testing | % peer clients completed any HIV testing since referral | Peer clients referred | Peer providersa | Month 3 |
PrEP continuation | % peer clients returned to a clinic and refilled PrEP since referral | Peer clients on PrEPb | Peer providersa | Month 3 |
PrEP adherence | % peer clients report being adherent to PrEP using validated scalesc; % with any TFV-DP detected in dried blood spot samples (random subset of participants) | Peer clients on PrEPb | Peer clients | Month 3 |
PrEP continuation (among peer providers) | % peer provider returned to a clinic to refill PrEP in the past 3 months | Peer providers | Peer providers | Month 3 |
Implementation outcomes | ||||
Acceptability | % of peer clients and peer providers who report our intervention model is acceptable using validated scalesc | Providers and referred clients | Providers and clients | Months 0 and 3 |
Appropriateness | % of peer clients and peer providers who report our intervention model is appropriate using validated scalesc | Providers and referred clients | Providers and clients | Months 0 and 3 |
Feasibility | % of peer clients and peer providers who report our intervention model is feasible using validated scalesc | Providers and referred clients | Providers and clients | Months 0 and 3 |
Fidelity | % of peer clients and peer providers who report delivering or receiving core components of the intervention (e.g., HIVST kits) | Providers and referred clients | Providers and clients | Month 3 |