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

NCT05417620 | Completed Results DMC

• 2 other identifiers: 90089975R01MH121161
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 1

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).

Conditions

Pre-exposure Prophylaxis; HIV Infections

Keywords

PrEP; Pre-exposure Prophylaxis; HIV prevention; Cluster randomized trial; Community-based methods; Key populations; Female sex workers; Adolescent girls and young women; South Africa

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (10)

• 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

• Adoption as Assessed by Number of Facebook Page Visits by Unique Users

  Month 12

• Total Cost

  Month 12

Study Arms (5)

Standard of Care

OTHER

Full-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.

Other: Standard of Care

Enhanced social media campaign

EXPERIMENTAL

Social media campaign which will be disseminated on Facebook, Instagram, and WhatsApp with targeted ads/promotion of materials in intervention districts.

Behavioral: Social Media Campaign

Enhanced social media campaign + PrEP champions

EXPERIMENTAL

Venue-based peers who will provide PrEP information, share personal experiences with PrEP, and refer young women to TB HIV Care to receive PrEP if interested in addition to the enhanced social media campaign.

Behavioral: Social Media Campaign; Behavioral: PrEP Champions

Enhanced social media campaign + Community mobilization

EXPERIMENTAL

Peers will work within wards to organize and attend community meetings to share PrEP information and facilitate discussions with young women, male partners, family members, and other community members in addition to the enhanced social media campaign.

Behavioral: Social Media Campaign; Behavioral: Community Mobilization

Enhanced social media campaign + PrEP champions + Community mobilization

EXPERIMENTAL

Clusters in this arm will receive both the PrEP champion and community mobilization interventions in addition to the enhanced social media campaign.

Behavioral: Social Media Campaign; Behavioral: PrEP Champions; Behavioral: Community Mobilization

Interventions

Social Media Campaign BEHAVIORAL

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.

Enhanced social media campaign; Enhanced social media campaign + Community mobilization; Enhanced social media campaign + PrEP champions; Enhanced social media campaign + PrEP champions + Community mobilization

PrEP Champions BEHAVIORAL

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.

Enhanced social media campaign + PrEP champions; Enhanced social media campaign + PrEP champions + Community mobilization

Community Mobilization BEHAVIORAL

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.

Enhanced social media campaign + Community mobilization; Enhanced social media campaign + PrEP champions + Community mobilization

Standard of Care OTHER

Full-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.

Standard of Care

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Eligibility to limited to cisgender women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible to take PrEP per TB HIV Care programmatic criteria
• Engaged in TB HIV Care HIV prevention program

You may not qualify if:

• Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Mental Health (NIMH): collaborator
• TB HIV Care: collaborator
• Community Media Trust: collaborator

Study Sites (1)

TB HIV Care

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

A limitation is using programmatic data to assess PrEP initiation among those accessing HIV testing through TB HIV Care. Since HIV testing and PrEP initiation programmatic data are not linked, we cannot determine the proportion of eligible women who initiate PrEP. Thus, we rely on PrEP initiation counts for the primary outcome.

Results Point of Contact

• Title: Dr. Sheree Schwartz
• Organization: Johns Hopkins Bloomberg School of Public Health

sschwartz@jhu.edu

443-983-2564

Study Officials

• Sheree R Schwartz, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 14, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 20, 2023
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)