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.