Clinical trial NCT05417620: Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
Official title: Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: TB HIV Care
name: Community Media Trust
First posted: 2022-06-14
Enrollment: 57901
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP uptake within the TB HIV Care programme
timeFrame: Month 0
Secondary outcomes:
measure: PrEP persistence at 1-month within the TB HIV Care programme
timeFrame: Month 1
measure: PrEP persistence at 4 months within the TB HIV Care programme
timeFrame: Month 4
measure: Acceptability
timeFrame: Month 12
measure: Adoption
timeFrame: Month 12
measure: Cost
timeFrame: Month 12
measure: Penetration
timeFrame: Month 12
measure: Fidelity
timeFrame: Month 12
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: TB HIV Care
state: Western Cape
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Sheree R Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References: