Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM

NCT03276338 | Completed

• 2 other identifiers: IRB000122925R01MH087339-04
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intervention is based on social cognitive theory and theory of empowerment education and was developed using community-based participatory research (CBPR). This study is a result of a long-term community-university partnership that has used and will continue to use CBPR throughout all phases of research. A total of 21 Latino MSM in rural NC have been screened and recruited to serve as LHAs. The CBPR partnership selected LHAs based on qualities of natural helpers and informal leaders and having existing social networks of other Latino MSM. Eight members of each LHA's social network have been screened and recruited to participate as well. The LHAs, coupled with their social networks, have been randomized to intervention or delayed-intervention groups. LHAs (n=11) in the intervention group were trained and serve as LHAs within their social networks in Year 2. Delayed-intervention LHAs (n=10) receive the same LHA training and serve as LHAs within their social networks in Year 3. Quantitative assessment data is collected from each LHA (n=21) and the 8 members of his social network (n=189) longitudinally at: (1) baseline, (2) immediate post-intervention, and (3) 12-month follow-up. This is an "intent-to-treat" study, in which participant data are analyzed based on their randomization group. The investigators hypothesize that participants in the HIV prevention intervention, relative to those in the delayed intervention comparison group, will demonstrate (1) increased self-reported use of condoms during sexual intercourse and (2) increased self-reported HIV testing. The results and products from this study will be disseminated to inform public health practice, research, and policy. Results and products will include: (1) a Spanish-language intervention that is: culturally congruent and gender-specific; designed to reduce HIV risk among Latino MSM; and ready for dissemination and adaptation; (2) a deeper understanding of HIV risk and intervention among Latino MSM; and (3) insight into a CBPR process that includes community members, organizational representatives, and academic researchers.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Change in condom use

  Evaluate the amount of condom use at from baseline to 4 months.

  4 months

Secondary Outcomes (1)

• Change in HIV status

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participation in the HOLA intervention designed to prevention HIV

Behavioral: HOLA

Delayed-intervention

NO INTERVENTION

Delayed intervention with participation in HOLA intervention after follow-up data have been collected

Interventions

HOLA BEHAVIORAL

To increase condom use and HIV testing

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender identity is an inclusion criterion
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as Latino or Hispanic;
• be 18 years of age;
• report MSM behavior since age 18;
• have some Spanish-language literacy;
• and provide informed consent.
• To be eligible to participate as a social network member of a Navegante, a participant must:
• self-identify as Latino or Hispanic;
• be 18 years of age;
• report MSM behavior since age 18;
• and provide informed consent.

You may not qualify if:

• having participated in the HoMBReS or HoMBReS-2 interventions, or in the refinement of the HOLA intervention.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Scott Rhodes

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: September 8, 2017
• Study Start: April 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: February 28, 2016
• Last Updated: August 10, 2018

Record last verified: 2018-08