HIV Infections, Pre-exposure Prophylaxis
Conditions
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
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.
Interventions
BEHAVIORALSocial 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.
BEHAVIORALPrEP 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.
BEHAVIORALCommunity 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.
OTHERStandard of Care
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.
Sponsors
National Institute of Mental Health (NIMH)
TB HIV Care
Community Media Trust
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme | Month 4 | 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. |
| Number of Participants Who Found Intervention Acceptable | Month 12 | Acceptability: Respondents who reported intervention acceptability captured in post-trial cross-sectional survey |
| Adoption as Assessed by Number of Facebook Page Visits by Unique Users | Month 12 | Service user uptake and engagement with campaign measured via the number of Facebook page visits. Facebook users who visited the campaign content is reported. |
| Total Cost | Month 12 | 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. |
| Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme | Month 1 | 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. |
| Fidelity as Assessed by Percentage of On-Schedule Posts | Month 12 | 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. |
| Adoption as Assessed by Number of Views by Unique Users | 12 months | Service user uptake and engagement with campaign as assessed by number of times each ad was viewed overall and number of video views. |
| Adoption as Assessed by Number of Ad Clicks | 12 months | Service user uptake and engagement with campaign measured via the number of times someone clicked on each ad |
| Fidelity as Assessed by Programme Logs Completed | 12 months | 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. |
| Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks | Month 12 | 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. |
Countries
South Africa
Participant flow
Pre-assignment details
A total of 601 participants were enrolled and engaged in HIV prevention services from the TB HIV Care Program. The TB HIV Care program had a total of 25,168 service-users in their database who initiated prep and were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care 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. | 301 |
| Standard of Care 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. | 50 |
| Enhanced Social Media Campaign/PrEP Champions/Community Mobilization PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. 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. | 92 |
| Enhanced Social Media Campaign/PrEP Champions/Community Mobilization PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. 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. | 27 |
| Enhanced Social Media Campaign + PrEP Champions 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. 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: Venue-based PrEP champions 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 that have repeated contact with the women the programme is intended to serve. | 55 |
| Enhanced Social Media Campaign + PrEP Champions 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. 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: Venue-based PrEP champions 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 that have repeated contact with the women the programme is intended to serve. | 26 |
| Enhanced Social Media Campaign + Community Mobilization 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. 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.
Community Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, 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. | 48 |
| Enhanced Social Media Campaign + Community Mobilization 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. 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.
Community Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, 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. | 26 |
| Enhanced Social Media Campaign + PrEP Champions + Community Mobilization 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. 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: Venue-based PrEP champions 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 that have repeated contact with the women the programme is intended to serve.
Community Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, 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. | 105 |
| Enhanced Social Media Campaign + PrEP Champions + Community Mobilization 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. 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: Venue-based PrEP champions 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 that have repeated contact with the women the programme is intended to serve.
Community Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, 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. | 26 |
| Total | 756 |
Baseline characteristics
| Characteristic | Standard of Care | Enhanced Social Media Campaign/PrEP Champions/Community Mobilization | Enhanced Social Media Campaign + PrEP Champions | Enhanced Social Media Campaign + Community Mobilization | Enhanced Social Media Campaign + PrEP Champions + Community Mobilization | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 23.8 years STANDARD_DEVIATION 7.8 | 26.4 years STANDARD_DEVIATION 7.8 | 28.2 years STANDARD_DEVIATION 8.8 | 25.2 years STANDARD_DEVIATION 7.8 | 24.7 years STANDARD_DEVIATION 7.2 | 24.9 years STANDARD_DEVIATION 7.9 |
| Age, Customized Age 15-17 | 80 Participants | 9 Participants | 2 Participants | 7 Participants | 12 Participants | 110 Participants |
| Age, Customized Age 18-24 | 117 Participants | 37 Participants | 21 Participants | 18 Participants | 51 Participants | 244 Participants |
| Age, Customized Age 25-29 | 33 Participants | 17 Participants | 7 Participants | 14 Participants | 20 Participants | 91 Participants |
| Age, Customized Age 30-34 | 32 Participants | 13 Participants | 11 Participants | 4 Participants | 12 Participants | 72 Participants |
| Age, Customized Age 35+ | 39 Participants | 16 Participants | 14 Participants | 5 Participants | 10 Participants | 84 Participants |
| Current Housing Status Brothel | 17 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Current Housing Status Owns/rents | 66 Participants | 30 Participants | 23 Participants | 14 Participants | 32 Participants | 165 Participants |
| Current Housing Status Shelter | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 10 Participants |
| Current Housing Status Staying with others (e.g., family, friends) | 200 Participants | 56 Participants | 29 Participants | 34 Participants | 59 Participants | 378 Participants |
| Current Housing Status Student housing | 5 Participants | 5 Participants | 3 Participants | 0 Participants | 12 Participants | 25 Participants |
| Currently Taking PrEP | 133 Participants | 58 Participants | 43 Participants | 27 Participants | 59 Participants | 320 Participants |
| Education Level Completed highschool | 93 Participants | 31 Participants | 17 Participants | 21 Participants | 24 Participants | 186 Participants |
| Education Level Completed university/trade school or higher | 22 Participants | 9 Participants | 4 Participants | 5 Participants | 4 Participants | 44 Participants |
| Education Level Currently in school | 142 Participants | 26 Participants | 15 Participants | 11 Participants | 57 Participants | 251 Participants |
| Education Level Did not complete highschool | 36 Participants | 16 Participants | 9 Participants | 10 Participants | 17 Participants | 88 Participants |
| Participants With Internet Access | 218 Participants | 69 Participants | 36 Participants | 30 Participants | 78 Participants | 431 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 297 Participants | 92 Participants | 54 Participants | 47 Participants | 104 Participants | 594 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Region of Enrollment South Africa | 301 Participants | 92 Participants | 55 Participants | 48 Participants | 105 Participants | 601 Participants |
| Relationship Status Single | 126 Participants | 32 Participants | 23 Participants | 13 Participants | 32 Participants | 226 Participants |
| Relationship Status Steady partner living together | 5 Participants | 21 Participants | 17 Participants | 12 Participants | 15 Participants | 70 Participants |
| Relationship Status Steady partner not living together | 169 Participants | 39 Participants | 14 Participants | 20 Participants | 58 Participants | 300 Participants |
| Sex: Female, Male Female | 301 Participants | 92 Participants | 55 Participants | 48 Participants | 105 Participants | 601 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smartphone Ownership | 224 Participants | 66 Participants | 40 Participants | 29 Participants | 74 Participants | 433 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 301 | 0 / 92 | 0 / 55 | 0 / 48 | 0 / 105 |
| other Total, other adverse events | 0 / 301 | 0 / 92 | 0 / 55 | 0 / 48 | 0 / 105 |
| serious Total, serious adverse events | 0 / 301 | 0 / 92 | 0 / 55 | 0 / 48 | 0 / 105 |
Outcome results
Primary
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.
Time frame: 12 months
Population: The analysis population are de-identified aggregate FSW and AGYW service-users in the TB HIV Care program database that initiated PrEP during the study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme | 17949 Participants |
| Enhanced Social Media Campaign | Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme | 3091 Participants |
| Enhanced Social Media Campaign + PrEP Champions | Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme | 924 Participants |
| Enhanced Social Media Campaign + Community Mobilization | Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme | 925 Participants |
| Enhanced Social Media Campaign + PrEP Champions + Community Mobilization | Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme | 2279 Participants |
Comparison: This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report rate = average counts of PrEP initiations per number of study months.p-value: 0.70795% CI: [0.44, 3.31]Regression, Poisson
Secondary
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
Time frame: 12 months
Population: As outlined in the protocol, adoption will be assessed using social media metrics and analytics from the number of unique users who have seen the Le Kip Kip Facebook page content at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Adoption as Assessed by Number of Ad Clicks | 35934 clicks |
Secondary
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.
Time frame: Month 12
Population: The analysis population is the number Facebook users that have seen the content.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Adoption as Assessed by Number of Facebook Page Visits by Unique Users | 52608 visits |
Secondary
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.
Time frame: 12 months
Population: As outlined in the protocol, adoption will be assessed using social media metrics and analytics from the number of unique users who have seen the Le Kip Kip Facebook page content at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Adoption as Assessed by Number of Views by Unique Users | Number of times each ad was viewed | 576384 views |
| Standard of Care | Adoption as Assessed by Number of Views by Unique Users | Number of times a video was viewed | 44081 views |
Secondary
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.
Time frame: Month 12
Population: As outlined in the protocol, participants were not included in assessing fidelity of on-schedule posts, rather posts made across social media platforms were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Standard of Care | Fidelity as Assessed by Percentage of On-Schedule Posts | Content Posting Frequency | 300 Posts |
| Standard of Care | Fidelity as Assessed by Percentage of On-Schedule Posts | Boosted Post Frequency | 100 Posts |
Secondary
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.
Time frame: 12 months
Population: As outlined in the protocol, the extent to which the social influence campaign was carried out according to plan as assessed via programme logs completed by PrEP champions and community mobilizers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Social Media Campaign | Fidelity as Assessed by Programme Logs Completed | Average reporting fidelity among PrEP champions | 49.2 percentage of campaign implementers |
| Enhanced Social Media Campaign | Fidelity as Assessed by Programme Logs Completed | Average reporting fidelity among community mobilizers | 86.4 percentage of campaign implementers |
Secondary
Number of Participants Who Found Intervention Acceptable
Acceptability: Respondents who reported intervention acceptability captured in post-trial cross-sectional survey
Time frame: Month 12
Population: As outlined in the protocol, acceptability of the social media campaign was assessed among post-intervention cross-sectional survey respondents who reported exposure to the Le Kip Kip social influence campaign.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Who Found Intervention Acceptable | 137 Participants |
Secondary
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.
Time frame: Month 12
Population: As outlined in the protocol, penetration of the social influence campaign is captured by post-intervention cross-sectional survey respondents from selected standard of care and intervention districts who answered questions regarding the reach of the Le Kip Kip campaign to their families, peers, and partners.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks | Families | 68 Participants |
| Standard of Care | Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks | Peers | 106 Participants |
| Standard of Care | Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks | Partners | 41 Participants |
Secondary
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.
Time frame: Month 1
Population: The analysis population are de-identified aggregate FSW and AGYW service-users in the TB HIV Care programme database who initiated PrEP during the trial period and due for a 1-month follow-up visit. The intervention arms are grouped under the social influence campaign intervention as per the study protocol's analytic approach.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme | 42.88 percentage of participants |
| Enhanced Social Media Campaign | Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme | 27.60 percentage of participants |
Secondary
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.
Time frame: Month 4
Population: The analysis population are de-identified aggregate FSW and AGYW service users in the TB HIV Care programme database who initiated PrEP during the trial period and due for a 4-month follow-up visit. The intervention arms are grouped under the social influence campaign intervention as per the study protocol's analytic approach.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme | 29.48 percentage of participants |
| Enhanced Social Media Campaign | Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme | 15.56 percentage of participants |
Secondary
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.
Time frame: Month 12
Population: This analysis does not involve any participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Social Media Campaign | Total Cost | 223736 Dollars |