Evaluating Demand Generation (Stylish Man , Stylish Living) for HIV Prevention/Family Planning Services, Rakai, Uganda

NCT02448823 | Completed

• 2 other identifiers: AI114438R01AI114438
• Study Type: interventional
• Target: 17,386
• Locations: 1 country
• Sites: 1

Brief Summary

The study tests a novel demand generation strategy, "Stylish Man/Stylish Living", to increase uptake of Combined HIV Prevention (CHP) in Rakai, Uganda. CHP includes safe voluntary medical male circumcision (VMMC), antiretroviral therapy (ART), and behavioral interventions. With President's Emergency Fund for AIDS Relief (PEPFAR) funds, the Rakai Health Sciences Program (RHSP) provides CHP in Rakai District, Uganda. Our ongoing 54 village Rakai Community Cohort Study (RCCS), with community HIV prevalence ranging from 6% to 42%, provides longitudinal data on rates of CHP coverage and on HIV incidence. There is preliminary evidence that CHP is reducing HIV incidence in Rakai, but CHP coverage remains suboptimal, particularly in men. Data suggest that CHP supply is not the limiting factor, but that there is a "deficit in demand". Based on extensive qualitative research, we developed an innovative male-focused CHP demand generation strategy, the "Stylish Man/Stylish Living Program" (SMLP) which is male-friendly without excluding women. SMLP strives to "demedicalize" CHP by de-emphasizing health-focused messages and instead stressing "taking charge of your life". It has two related elements: (1) mass media (MM) via radio and posters; and (2) community-level mobilization via the "Stylish Man/Stylish Living Event" (SMLEvent) which includes CHP promotion through multimedia (the Stylish Van, videos, music, health promoters) and immediate access to services (mobile camps which offer VMMC camps, HIV testing and counseling services, referral for ART, and contraceptive services). In this study, the investigators will conduct a 4.5 year cluster randomized trial of MM/mobile service camps+SMLEvents (intervention arm) compared to MM/mobile service camps conducted without SMLEvents (control), in 25 RCCS communities per arm aggregated into \~10 clusters per arm (50 communities in all). The primary outcome will be intent-to-treat community-level rates of CHP coverage by arm, and service statistics on use of mobile camp services by arm. The investigators will also monitor rates of key behaviors and HIV incidence, and compare them between arms and to rates observed in communities in each arm prior to study initiation (secondary outcomes).

Conditions

HIV

Keywords

HIV; combined prevention; demand generation

Outcome Measures

Primary Outcomes (2)

• Community level uptake of selected combined HIV prevention services (HIV testing and counseling services, VMMC, referral for HIV care/ART, family planning.

  Clients will be asked what motivated them to accept a service (some SMLP component, other people were getting services, encouragement from someone influenced by the SMLP, factors unrelated to the SMLP, etc…) We will track whether persons referred for HIV care/ART present to our HIV clinics (and conversely, we will ask about clinic attendance during each RCCS survey rounds). Routine HIV clinic data collection includes tracking of visits, questions on adherence, and CD4 cell count every 6 months

  5 year study

• Service statics in mobile service camps in each study arm

  Data will be recorded regarding the numbers and characteristics of clients accepting HIV counseling and testing services, VMMC, referral for ART, and family planning, by age, gender and community.

  5 year study

Secondary Outcomes (1)

• Selected HIV risk behaviors and HIV incidence

  5 year study

Study Arms (2)

Stylish Events and Mass Media

EXPERIMENTAL

Mass Media (radio, posters) and annual Stylish Man/Stylish Living Event (SMLEvent), a multimedia event promoting CHP.

Other: Mass media and Stylish Events

Control arm: mass media only

ACTIVE COMPARATOR

Mass media

Other: Mass Media

Interventions

Mass media and Stylish Events OTHER

1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters. 2. "Stylish Man/Living Event" (SMLEvent) community mobilization/service provision. SMLEvent activities. Messages on how CHP (including behaviors such as sexual risk reduction) can make men and women feel more in control of their lives, less stressed, and more "Stylish" are interwoven through the mobilization. The Stylish Man Van (SMV) accompanies the SMLEvent. The Van includes multimedia and health mobilizers who insert HIV prevention messages, testimonials by satisfied CHP "customers" and where appropriate their spouses.

Stylish Events and Mass Media

Mass Media OTHER

1\. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.

Control arm: mass media only

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Residents aged 18-49 years in the 50 communities. (Please note: this is a community-randomized trial)

You may not qualify if:

• All community residents may attend the events and by definition, will be exposed to mass media. However, only persons aged 18-49 who sign or fingerprint a written informed consent will be interviewed in the RCCS as part of the evaluation nested within the RCCS.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Rakai Health Sciences Program: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Rakai Health Sciences Program

Kalisizo, Rakai District, Uganda

Location

Study Officials

• Maria J Wawer, MD, MHSc

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: May 20, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 25, 2022

Record last verified: 2019-04

Locations

UG (1)