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Completed

NCT Number: NCT00877695

Motiv82Change: an HIV Prevention Study for Young Latino Men

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nova Southeastern University (Miami Office)

Miami, Florida, 33137, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible, participants must:

  • be male;
  • self-identify as Hispanic/Latino;
  • be 18 - 29 years of age;
  • live in South Florida;
  • have had at least 1 episode of unprotected anal sex with a man in the last 6 months;
  • have had at least 2 male sex partners in the last 6 months;
  • be HIV negative or not known to be HIV positive; and
  • have not previously participated in this study.

Exclusion criteria

  • living with HIV infection

Treatment and study plan

Entre Culturas: Navigating Culture, Identity, and HIV Risk

Behavioral

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.

Other names: Young Hispanic MSM, HIV prevention interventions, Motiv8 2Change

Primary outcomes

  1. 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

  1. acceptability and feasibility of the intervention

    Time frame: 16 months

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

Young Hispanic Men "Entre Culturas": Navigating Culture, Identity and HIV Risk

Acronym: Motiv82Change

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2009
Registry last updated
Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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