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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05417620
• Other study ID #: 90089975
• Secondary ID: R01MH121161
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 57901
• Est. completion date: November 20, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Pre-exposure Prophylaxis

Intervention

Behavioral:
• Social Media Campaign
PrEP 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.
• PrEP Champions
Within 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.
• Community Mobilization
A 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.

Locations

Country	Name	City	State
South Africa	TB HIV Care	Cape Town	Western Cape

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Community Media Trust, National Institute of Mental Health (NIMH), TB/HIV Care

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP uptake within the TB HIV Care programme	Proportion of FSW/AGYW clients within the TB HIV Care PrEP programme who initiate PrEP among all eligible marginalized young women to whom it is offered.	Month 0
Secondary	PrEP persistence at 1-month within the TB HIV Care programme	Proportion of FSW/AGYW clients within the TB HIV Care programme who return for 1-month follow-up visit.	Month 1
Secondary	PrEP persistence at 4 months within the TB HIV Care programme	Proportion of FSW/AGYW clients within the TB HIV Care programme who return for 4-month follow-up visit.	Month 4
Secondary	Acceptability	Satisfaction with social influence campaign components measured via descriptive statistics captured in post-trial cross-sectional survey	Month 12
Secondary	Adoption	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.	Month 12
Secondary	Cost	Costs associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets.	Month 12
Secondary	Penetration	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.	Month 12
Secondary	Fidelity	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.	Month 12