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Clinical Trials/NCT05417620
NCT05417620
Completed
Not Applicable

Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa

Johns Hopkins Bloomberg School of Public Health1 site in 1 country601 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-exposure Prophylaxis
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
601
Locations
1
Primary Endpoint
Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme
Status
Completed
Last Updated
9 months ago

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
November 20, 2023
Last Updated
9 months ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Eligibility Criteria

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

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)

Study Sites (1)

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