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

Primary Purpose

Pre-exposure Prophylaxis, HIV Infections

Status

Recruiting

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Social Media Campaign

PrEP Champions

Community Mobilization

About this trial

This is an interventional health services research trial for Pre-exposure Prophylaxis focused on measuring PrEP, Pre-exposure Prophylaxis, HIV prevention, Cluster randomized trial, Community-based methods, Key populations, Female sex workers, Adolescent girls and young women, South Africa

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

TB HIV CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Enhanced social media campaign

Enhanced social media campaign + PrEP champions

Enhanced social media campaign + Community mobilization

Enhanced social media campaign + PrEP champions + Community mobilization

Arm Description

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.

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

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Acceptability

Satisfaction with social influence campaign components measured via descriptive statistics captured in post-trial cross-sectional survey

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.

Cost

Costs associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets.

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.

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.

Full Information

NCT ID

NCT05417620

First Posted

June 2, 2022

Last Updated

October 10, 2023

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Mental Health (NIMH), TB/HIV Care, Community Media Trust

1. Study Identification

Unique Protocol Identification Number

NCT05417620

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Actual)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Mental Health (NIMH), TB/HIV Care, Community Media Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35075 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Arm Title

Enhanced social media campaign

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced social media campaign + PrEP champions

Arm Type

Experimental

Arm Description

Arm Title

Enhanced social media campaign + Community mobilization

Arm Type

Experimental

Arm Description

Arm Title

Enhanced social media campaign + PrEP champions + Community mobilization

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Social Media Campaign

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

PrEP Champions

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Community Mobilization

Intervention Description

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.

Primary Outcome Measure Information:

Title

PrEP uptake within the TB HIV Care programme

Description

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.

Time Frame

Month 0

Secondary Outcome Measure Information:

Title

PrEP persistence at 1-month within the TB HIV Care programme

Description

Proportion of FSW/AGYW clients within the TB HIV Care programme who return for 1-month follow-up visit.

Time Frame

Month 1

Title

PrEP persistence at 4 months within the TB HIV Care programme

Description

Proportion of FSW/AGYW clients within the TB HIV Care programme who return for 4-month follow-up visit.

Time Frame

Month 4

Title

Acceptability

Description

Satisfaction with social influence campaign components measured via descriptive statistics captured in post-trial cross-sectional survey

Time Frame

Month 12

Title

Adoption

Description

Time Frame

Month 12

Title

Cost

Description

Costs associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets.

Time Frame

Month 12

Title

Penetration

Description

Time Frame

Month 12

Title

Fidelity

Description

Time Frame

Month 12

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Eligibility to limited to cisgender women

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheree R Schwartz, PhD

Phone

410-502-9298

sschwartz@jhu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Lillian M Shipp, MSPH

Phone

410-502-9048

lshipp2@jhu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheree R Schwartz, PhD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

TB HIV Care

City

Cape Town

State/Province

Western Cape

Country

South Africa

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harry Hausler, MD, PhD, MPH

Phone

+27214250050

hhausler@tbhivcare.org

First Name & Middle Initial & Last Name & Degree

Chitra Singh, MS

Phone

+27334320067

chitra.singh@tbhivcare.org

First Name & Middle Initial & Last Name & Degree

Harry Hausler, MD, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Aggregate programmatic data will be used to assess trial outcomes rather than individual participant data given the cluster randomized trial design. Therefore, no IPD will be collected and no sharing plan is required.

Learn more about this trial

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

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