NCT03276338: HOLA

Using CBPR to Reduce HIV Risk Among Immigrant Latino MSM

Completed NA Last updated 10 August 2018

What this trial tests

NA trial testing HOLA in HIV/AIDS in 186 participants. Completed in 28 February 2016.

Timeline

1 April 2011

Primary endpoint
1 June 2015

28 February 2016

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	186
Start date	1 April 2011
Primary completion	1 June 2015
Estimated completion	28 February 2016

Drugs / interventions tested

• HOLA

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, male only, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.