Pre-exposure ProphylaxisNCT05417620
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
A study testing Social Media Campaign, PrEP Champions and Community Mobilization in people with Pre-exposure Prophylaxis and HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Pre-exposure Prophylaxis, HIV Infections
- What is being tested?
- Social Media Campaign, PrEP Champions and Community Mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Oct 2022to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible to take PrEP per TB HIV Care programmatic criteria
- Engaged in TB HIV Care HIV prevention program
Who cannot join
- Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa
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).
Read the 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
- Pre-exposure Prophylaxis, HIV Infections
- Being tested
- Social Media Campaign, PrEP Champions, Community Mobilization, Standard of Care
- 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
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Media CampaignBehavioural
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 ChampionsBehavioural
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 MobilizationBehavioural
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Social Media Campaign; Behavioral: PrEP Champions; Behavioral: Community Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme
Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 1-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.
Measured: Month 1
Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme
Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 4-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.
Measured: Month 4
Number of Participants Who Found Intervention Acceptable
Acceptability: Respondents who reported intervention acceptability captured in post-trial cross-sectional survey
Measured: Month 12
Adoption as Assessed by Number of Facebook Page Visits by Unique Users
Service user uptake and engagement with campaign measured via the number of Facebook page visits. Facebook users who visited the campaign content is reported.
Measured: Month 12
Total Cost
Total cost associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets. The reported value represents a single point estimate (in USD) of the total cost incurred, based on actual budget expenditures. Because this is a cumulative total cost, non-sampled financial figure, measures of dispersion/precision are not applicable. This outcome measure is based on a review of detailed study budgets related to the planning, design, and implementation of the social influence campaign.The unit analyzed is the campaign itself and analyzed as the overall cost of the Enhanced social media campaign/PrEP champions/Community mobilization arm per protocol.
Measured: Month 12
Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks
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.
Measured: Month 12
Fidelity as Assessed by Percentage of On-Schedule Posts
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. Fidelity is assessed by tracking adherence to the planned posting schedule. Participants were not included in assessing fidelity of on-schedule posts, rather posts made across social media platforms were analyzed. Adherence was assessed by documenting whether all scheduled posts were successfully and timely published as planned during the campaign period.
Measured: Month 12
Adoption as Assessed by Number of Views by Unique Users
Service user uptake and engagement with campaign as assessed by number of times each ad was viewed overall and number of video views.
Measured: 12 months
Adoption as Assessed by Number of Ad Clicks
Service user uptake and engagement with campaign measured via the number of times someone clicked on each ad
Measured: 12 months
Fidelity as Assessed by Programme Logs Completed
Extent to which the social influence campaign was carried out according to plan was measured via trainings, logs of communication with PrEP champions, and community mobilization logs/quality assessments.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-exposure ProphylaxisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), TB HIV Care, Community Media Trust
- Responsible party
- Sponsor
- Investigators
- Sheree R Schwartz, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417620
- Sponsor's protocol ID
- 90089975
- Other IDs
- R01MH121161
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2022
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate programmatic data will be used to assess trial outcomes rather than individual participant data given the cluster randomized trial design. Therefore, no individual participant data (IPD) will be collected and no sharing plan is required.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa
- ClinicalTrials.gov ID
- NCT05417620
- Acronym / sponsor ID
- 90089975
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), TB HIV Care, Community Media Trust
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 30 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard 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. |
| Enhanced social media campaign | Experimental | Behavioral: Social Media CampaignSocial media campaign which will be disseminated on Facebook, Instagram, and WhatsApp with targeted ads/promotion of materials in intervention districts. |
| Enhanced social media campaign + PrEP champions | Experimental | Behavioral: Social Media Campaign, Behavioral: PrEP ChampionsVenue-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. |
| Enhanced social media campaign + Community mobilization | Experimental | Behavioral: Social Media Campaign, Behavioral: Community MobilizationPeers 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. |
| Enhanced social media campaign + PrEP champions + Community mobilization | Experimental | Behavioral: Social Media Campaign, Behavioral: PrEP Champions, Behavioral: Community MobilizationClusters in this arm will receive both the PrEP champion and community mobilization interventions in addition to the enhanced social media campaign. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible to take PrEP per TB HIV Care programmatic criteria
- Engaged in TB HIV Care HIV prevention program
Key exclusion criteria (1 listed)
- Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social 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. | Behavioural | 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 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. | Behavioural | Enhanced social media campaign + PrEP champions, Enhanced social media campaign + PrEP champions + Community mobilization |
| Community 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. | Behavioural | Enhanced social media campaign + Community mobilization, Enhanced social media campaign + PrEP champions + Community mobilization |
| Standard 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. | Other | Standard of Care |
Primary outcome
Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme
Time frame: 12 months
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.
10 secondary outcomes
Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme
Time frame: Month 1
Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme
Time frame: Month 4
Number of Participants Who Found Intervention Acceptable
Time frame: Month 12
Adoption as Assessed by Number of Facebook Page Visits by Unique Users
Time frame: Month 12
Total Cost
Time frame: Month 12
Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks
Time frame: Month 12
Fidelity as Assessed by Percentage of On-Schedule Posts
Time frame: Month 12
Adoption as Assessed by Number of Views by Unique Users
Time frame: 12 months
Adoption as Assessed by Number of Ad Clicks
Time frame: 12 months
Fidelity as Assessed by Programme Logs Completed
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Aggregate programmatic data will be used to assess trial outcomes rather than individual participant data given the cluster randomized trial design. Therefore, no individual participant data (IPD) will be collected and no sharing plan is required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheree R Schwartz, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media Campaign, PrEP Champions and Community Mobilization in people with Pre-exposure Prophylaxis and HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.