A hybrid design testing a 3-step implementation model for community scale-up of an HIV prevention intervention in rural Malawi: study protocol.

BACKGROUND: Scaling-up evidence-based behavior change interventions can make a major contribution to meeting the UNAIDS goal of no new HIV infections by 2030. We developed an evidence-based peer group intervention for HIV prevention and testing in Malawi that is ready for wider dissemination. Our innovative approach turns over ownership of implementation to rural communities. We adapted a 3-Step Implementation Model (prepare, roll-out and sustain) for communities to use. Using a hybrid design, we simultaneously evaluate community implementation processes and program effectiveness. METHODS: Three communities in southern Malawi begin implementation in randomly-assigned order using a stepped wedge design. Our evaluation sample size of 144 adults and 144 youth per community provides sufficient power to examine primary outcomes of condom use and HIV testing. Prior to any implementation, the first participants in all three communities are recruited and complete the Wave 1 baseline survey. Waves 2-4 surveys occur after each community completes roll-out. Each community follows the model's three steps. During Prepare, the community develops a plan and trains peer group leaders. During Roll-Out, peer leaders offer the program. During Sustain, the community makes and carries out plans to continue and expand the program and ultimately obtain local funding. We evaluate degree of implementation success (Aim 1) using the community's benchmark scores (e.g, # of peer groups held). We assess implementation process and factors related to success (Aim 2) using repeated interviews and observations, benchmarks from Aim 1 and fidelity assessments. We assess effectiveness of the peer group intervention when delivered by communities (Aim 3) using multi-level regression models to analyze data from repeated surveys. Finally, we use mixed methods analyses of all data to assess feasibility, acceptability and sustainability (Aim 4). DISCUSSION: The project is underway, and thus far the first communities have enthusiastically begun implementation. We have had to make several modifications along the way, such as moving from rapid-tests of STIs to symptoms screening by a nurse due to problems with test reliability and availability. If successful, results will provide a replicable evidence-based model for future community implementation of this and other health interventions. TRIAL REGISTRATION: Clinical Trials.gov NCT02765659 Registered May 6, 2016.

Outcomes of an HIV prevention peer group intervention for rural adults in Malawi.

This study used a quasi-experimental design to evaluate a six-session peer group intervention for HIV prevention among rural adults in Malawi. Two rural districts were randomly assigned to intervention and control conditions. Independent random samples of community adults compared the districts at baseline and at 6 and 18 months postintervention. Using multiple regressions controlling for six demographic factors, intervention district adults had significantly more favorable outcomes at 6- and 18-month evaluations for condom attitudes, self-efficacy for community prevention, self-efficacy for practicing safer sex, partner communication, using condoms ever in the past 2 months, and community prevention activities. Knowledge and hope for controlling the epidemic were significantly higher in the intervention district only at the 6-month evaluation; having a recent HIV test was significantly higher only at 18 months. Levels of stigma and the number of risky sex practices did not decrease when demographic factors were controlled. Expanding peer group intervention for HIV prevention would benefit rural adults.

Process evaluation of HIV prevention peer groups in Malawi: a look inside the black box.

This paper reports the process evaluation of a peer group intervention for human immunodeficiency virus (HIV) prevention which had positive outcomes for three target groups in Malawi: rural adults, adolescents and urban hospital workers. The six-session intervention was delivered to small groups of 10-12 participants by 85 trained volunteer peer leaders working in pairs. A descriptive, observational mixed methods design was used with a convenience sample of 294 intervention sessions. Using project records and a conceptually based observation guide, we examined five aspects of the implementation process. The context was favorable, but privacy to discuss sensitive issues was a concern for some groups. In study communities, program reach was 58% of rural adults, 70% of adolescents and nearly all hospital workers. Session records confirmed that all peer groups received the intended six sessions (dose delivered). The dose received was high, as evidenced by high participant engagement in peer group activities. Peer leaders were rated above the median for three indicators of peer group content and process fidelity: session management skills, interpersonal facilitation skills and whether more like a peer group than classroom. Documenting that this HIV prevention peer group intervention was delivered as intended by trained peer volunteers supports widespread dissemination of the intervention.