Motiv82Change: an HIV Prevention Study for Young Latino Men

Nova Southeastern University200 enrolled

Overview

The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).

Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot testing of interventions. The formative research leading to and including intervention development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data and obtain effect size estimates of the intervention's strength in changing a desired outcome is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full scale efficacy testing in Stage 2 using the classic experimental design of a randomized control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after its efficacy has been demonstrated in at least two Stage 2 trials.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

HIV Infections

Interventions

Entre Culturas: Navigating Culture, Identity, and HIV RiskBEHAVIORAL

A pilot test of a culturally and developmentally tailored MEI to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM) to be delivered face-to-face (FtF) and through the Internet using a real-time implementation approach. A tailored MEI for two delivery modalities, and a health education control (HEALTH) comparable in time and number of sessions. We will test the MEI's acceptability and feasibility, obtain effect size estimates of the intervention's strength to reduce risky sex, and determine if it is ready for efficacy testing.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: To be eligible, participants must: 1. be male; 2. self-identify as Hispanic/Latino; 3. be 18 - 29 years of age; 4. live in South Florida; 5. have had at least 1 episode of unprotected anal sex with a man in the last 6 months; 6. have had at least 2 male sex partners in the last 6 months; 7. be HIV negative or not known to be HIV positive; and 8. have not previously participated in this study. Exclusion Criteria: 1\. living with HIV infection

Locations (1)

Nova Southeastern University (Miami Office)

Miami, Florida, United States

Outcomes

Primary Outcomes

The main outcome measure for the Stage 1b trial will be reduction in at least one of the two main outcome variables - number of unprotected anal sex acts and number of sex partners (both in the last 3 months).

Time frame: 16 months

Secondary Outcomes

acceptability and feasibility of the intervention

Time frame: 16 months

Data from ClinicalTrials.gov

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