Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 601
- Locations
- 1
- Primary Endpoint
- Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme
Study Overview
Brief Summary
The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in South Africa. To do this, the investigative team will analyze PrEP initiation and retention data from the study's implementing partner, TB HIV Care, a non-profit organization providing PrEP to marginalized young women in South Africa. The effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (CRT).
Detailed Description
The cluster randomized trial (CRT) will not engage in PrEP provision to individuals, but instead employs geographical regions to serve as units of randomization where social media content and community engagement will be targeted. TB HIV Care employs a large team to provide routine service delivery while the CRT tests strategies including a social media campaign and community engagement that may amplify PrEP uptake and persistence among the community, leveraging the programme infrastructure to actually provide services as it is already doing. Embedding strategies within the programme ensures that the existing results come from real world contexts and focuses on implementation of support strategies rather than clinical care provision. The CRT will be implemented across 10 districts, with 5 districts serving as control sites and 5 as intervention sites.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible to take PrEP per TB HIV Care programmatic criteria
- •Engaged in TB HIV Care HIV prevention program
Exclusion Criteria
- •Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria
Arms & Interventions
Standard of Care
Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
Intervention: Standard of Care (Other)
Enhanced social media campaign
Social media campaign which will be disseminated on Facebook, Instagram, and WhatsApp with targeted ads/promotion of materials in intervention districts.
Intervention: Social Media Campaign (Behavioral)
Enhanced social media campaign + PrEP champions
Venue-based peers who will provide PrEP information, share personal experiences with PrEP, and refer young women to TB HIV Care to receive PrEP if interested in addition to the enhanced social media campaign.
Intervention: Social Media Campaign (Behavioral)
Enhanced social media campaign + PrEP champions
Venue-based peers who will provide PrEP information, share personal experiences with PrEP, and refer young women to TB HIV Care to receive PrEP if interested in addition to the enhanced social media campaign.
Intervention: PrEP Champions (Behavioral)
Enhanced social media campaign + Community mobilization
Peers will work within wards to organize and attend community meetings to share PrEP information and facilitate discussions with young women, male partners, family members, and other community members in addition to the enhanced social media campaign.
Intervention: Social Media Campaign (Behavioral)
Enhanced social media campaign + Community mobilization
Peers will work within wards to organize and attend community meetings to share PrEP information and facilitate discussions with young women, male partners, family members, and other community members in addition to the enhanced social media campaign.
Intervention: Community Mobilization (Behavioral)
Enhanced social media campaign + PrEP champions + Community mobilization
Clusters in this arm will receive both the PrEP champion and community mobilization interventions in addition to the enhanced social media campaign.
Intervention: PrEP Champions (Behavioral)
Enhanced social media campaign + PrEP champions + Community mobilization
Clusters in this arm will receive both the PrEP champion and community mobilization interventions in addition to the enhanced social media campaign.
Intervention: Community Mobilization (Behavioral)
Enhanced social media campaign + PrEP champions + Community mobilization
Clusters in this arm will receive both the PrEP champion and community mobilization interventions in addition to the enhanced social media campaign.
Intervention: Social Media Campaign (Behavioral)
Outcomes
Primary Outcomes
Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme
Time Frame: 12 months
De-identified aggregate counts of female sex workers (FSW) and adolescent girls and young women (AGYW) service-users within the TB HIV Care programme database who initiate PrEP during the intervention period. Number of service users in the program database who initiated prep are reported.
Secondary Outcomes
- Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme(Month 1)
- Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme(Month 4)
- Number of Participants Who Found Intervention Acceptable(Month 12)
- Fidelity as Assessed by Percentage of On-Schedule Posts(Month 12)
- Adoption as Assessed by Number of Facebook Page Visits by Unique Users(Month 12)
- Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks(Month 12)
- Adoption as Assessed by Number of Views by Unique Users(12 months)
- Adoption as Assessed by Number of Ad Clicks(12 months)
- Fidelity as Assessed by Programme Logs Completed(12 months)
- Total Cost(Month 12)