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: 601

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
Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme	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 Outcome Measures

Name	Time	Method
Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme	Month 1	Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 1-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.
Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme	Month 4	Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 4-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.
Number of Participants Who Found Intervention Acceptable	Month 12	Acceptability: Respondents who reported intervention acceptability captured in post-trial cross-sectional survey
Fidelity as Assessed by Percentage of On-Schedule Posts	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. Fidelity is assessed by tracking adherence to the planned posting schedule. Participants were not included in assessing fidelity of on-schedule posts, rather posts made across social media platforms were analyzed. Adherence was assessed by documenting whether all scheduled posts were successfully and timely published as planned during the campaign period.
Adoption as Assessed by Number of Facebook Page Visits by Unique Users	Month 12	Service user uptake and engagement with campaign measured via the number of Facebook page visits. Facebook users who visited the campaign content is reported.
Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks	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.
Adoption as Assessed by Number of Views by Unique Users	12 months	Service user uptake and engagement with campaign as assessed by number of times each ad was viewed overall and number of video views.
Adoption as Assessed by Number of Ad Clicks	12 months	Service user uptake and engagement with campaign measured via the number of times someone clicked on each ad
Fidelity as Assessed by Programme Logs Completed	12 months	Extent to which the social influence campaign was carried out according to plan was measured via trainings, logs of communication with PrEP champions, and community mobilization logs/quality assessments.
Total Cost	Month 12	Total cost associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets. The reported value represents a single point estimate (in USD) of the total cost incurred, based on actual budget expenditures. Because this is a cumulative total cost, non-sampled financial figure, measures of dispersion/precision are not applicable. This outcome measure is based on a review of detailed study budgets related to the planning, design, and implementation of the social influence campaign.The unit analyzed is the campaign itself and analyzed as the overall cost of the Enhanced social media campaign/PrEP champions/Community mobilization arm per protocol.