Participatory development and pilot testing of the Makasi intervention: a community-based outreach intervention to improve sub-Saharan and Caribbean immigrants' empowerment in sexual health.

Background: Sub-Saharan and Caribbean immigrants are particularly affected by HIV in Europe, and recent evidence shows that a large portion of them acquired HIV after arrival. There is a need for efficient interventions that can reduce immigrants' exposure to HIV. We describe the pilot phase of a community-based empowerment outreach intervention among sub-Saharan and Caribbean immigrants in the greater Paris area aimed at 1) constructing the intervention, 2) assessing its feasibility, and 3) assessing the feasibility of its evaluation based on a stepped-wedge approach.

Methods: 1) To develop the intervention, a literature review was conducted on existing interventions and participatory approaches developed, including the constitution of peer groups. 2) To assess the intervention's feasibility, a pilot was conducted between April 2018 and December 2018. A daily register was used to collect data on sociodemographic characteristics of all persons who visited the mobile team to assess eligibility and acceptability. 3) To assess the feasibility of performing a stepped-wedge trial to evaluate the intervention, we compared eligibility, enrolment and retention at 3 months in two arms (immediate vs deferred). Chi-squared tests were used to compare reach and retention between the two arms.

Results: Intervention development. The Makasi intervention was designed as an outreach intervention that starts with the persons' capacities and helps them appropriate existing resources and information and obtain knowledge about sexual health, based upon motivational interviewing techniques. Intervention Feasibility. Between April 2018 and December 2018, a total of 485 persons were identified as eligible. Participation in the intervention was proposed to 79% of eligible persons. When proposed, the persons enrolled in the intervention with a response rate of 69%. Some were lost to follow-up, and 188 persons were finally included. Evaluation Feasibility. The proportions of eligible (45 and 42%) individuals and of enrolled individuals (65 and 74%) were similar and not significantly different in the immediate and deferred arms, respectively.

Conclusions: A community-based outreach intervention aimed at improving sub-Saharan and Caribbean immigrants' empowerment in sexual health is feasible. The pilot phase was key to identifying challenges, designing a relevant intervention and validating the stepped-wedge protocol for evaluation.