Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa

Not Applicable

Completed

Conditions: HIV Infections
Pre-exposure Prophylaxis

Registration Number: NCT05417620

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 57901

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
PrEP uptake within the TB HIV Care programme	Month 0	Proportion of Female sex workers (FSW), Adolescent girls and young women (AGYW) clients within the TB HIV Care PrEP programme who initiate PrEP among all eligible marginalized young women to whom it is offered.

Secondary Outcome Measures

Name	Time	Method
Fidelity	Month 12	Extent to which the social influence campaign was carried out according to plan measured via social media metrics to determine whether static and video content were shared across platforms as planned and via program logs/quality assessments of community mobilization and PrEP champion activities to determine the degree to which implementation activities were carried out as planned.
PrEP persistence at 1-month within the TB HIV Care programme	Month 1	Proportion of FSW/AGYW clients within the TB HIV Care programme who return for 1-month follow-up visit.
Cost	Month 12	Costs associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets.
PrEP persistence at 4 months within the TB HIV Care programme	Month 4	Proportion of FSW/AGYW clients within the TB HIV Care programme who return for 4-month follow-up visit.
Adoption	Month 12	Service user uptake and engagement with campaign measured via the number of times each ad was viewed overall and by an individual, number of times someone clicked on each ad, and the click-through rate metric which tells you the percentage of people who click an ad out of all the people who saw the ad; the team will also assess the number of website/Facebook page visits, video views and appointments made with TB HIV Care program.
Acceptability	Month 12	Satisfaction with social influence campaign components measured via descriptive statistics captured in post-trial cross-sectional survey
Penetration	Month 12	Extent to which the social influence campaign reached FSW/AGYW and their families/peers/partners measured via descriptive statistics from post-trial survey questions on campaign exposure and perceptions of the campaign among FSW/AGYW and their social support networks.