Clinical Trials Directory

Trials / Completed

CompletedNCT05417620

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
601 (actual)
Sponsor
Johns Hopkins Bloomberg School of Public Health · Academic / Other
Sex
Female
Age
15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSocial Media CampaignPrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. Messaging crafted with community input will be geographically targeted to women, parents/mentors, and male partners on Facebook, Instagram, and Whatsapp, all with the intention to promote PrEP for women at high risk of HIV infection and change community norms and influence around PrEP. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.
BEHAVIORALPrEP ChampionsWithin venues served by the FSW and AGYW programs, the team will identify and train 1 venue-based PrEP champion per venue who will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers (e.g. women running shops next to the mobile serving AGYW) that have repeated contact with the women the programme is intended to serve. The final selection of PrEP champions will be made in consultation with the Community Advisory Groups, venues and by the programme who works closely with each of the sites.
BEHAVIORALCommunity MobilizationA PrEP community mobilization team (2 peers, including one woman and one man) will be recruited within each ward to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, at Learning Support Agent meetings with parents/guardians, at local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma. Each team will focus on promoting PrEP within their own ward over the 6-month period.
OTHERStandard of CareFull-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.

Timeline

Start date
2022-10-01
Primary completion
2023-09-30
Completion
2023-11-20
First posted
2022-06-14
Last updated
2025-07-30
Results posted
2025-07-30

Locations

1 site across 1 country: South Africa

Source: ClinicalTrials.gov record NCT05417620. Inclusion in this directory is not an endorsement.