Clinical trial NCT03432819: A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Official title: A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Latino, men who have sex with men
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Bienestar Human Services, Inc.
First posted: 2018-02-14
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: R34-funded study to pilot test an intervention to improve coping with discrimination and adherence among Latino men who have sex with men (MSM) living with HIV. The proposed research aims to modify and refine Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for HIV-positive Latino men who have sex with men (LMSM), to include strategies for ART adherence and retention in HIV care; and to conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on coping responses to discrimination and antiretroviral treatment adherence among LMSM living with HIV.

Detailed description: HIV-related disparities in diagnosis and disease outcomes persist among Latinos, and Latinos living with HIV show a lower percentage of viral suppression compared to the general HIV-positive population. A growing body of work suggests that stigma and discrimination contribute to health disparities, especially among people living with HIV, who may experience discrimination due to multiple stigmatized identities related to HIV-serostatus, race/ethnicity, and sexual orientation. Internalized stigma and discrimination may lead to health-related disparities by increasing detrimental physiological stress responses, resulting in maladaptive coping and poor health behaviors, including non-adherence to treatment. Moreover, the chronic stress of discrimination may weaken immune function, leading to worse HIV outcomes, including increased HIV viral load. The proposed research will integrate adherence skills-building strategies into a recently developed intervention, Siempre Seguiré, an 8-session group cognitive behavioral therapy (CBT) intervention for HIV-positive Latino men who have sex with men (LMSM) that aims to improve adaptive coping responses to discrimination. The specific aims are: (1) To modify and refine Siempre Seguiré, a newly developed culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for antiretroviral treatment adherence and retention in HIV care; and (2) To conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on: (a) coping responses to discrimination; and (b) antiretroviral treatment adherence, viral load suppression, and HIV care retention, among LMSM living with HIV. In Phase 1, HIV treatment adherence intervention experts and key stakeholders, including a community advisory board, will help to refine our pilot intervention as needed and update our manual to integrate information and skills building regarding HIV treatment adherence and retention in care. In Phase 2, a small randomized controlled trial of 80 participants (40 intervention participants divided evenly over 4 intervention groups vs. 40 wait-list control participants) will be conducted. Participants will complete surveys at baseline, and 4- and 6-months post-baseline to assess coping and HIV care processes and outcomes. Adherence will be electronically monitored, and viral load will be collected from medical providers at baseline and at 6-month follow-up. Intervention group sessions will take place once per week for 8 weeks. Sessions will take place in a private room at Bienestar (a Latino-serving AIDS service organization in LAC) and will last approximately 90 minutes. We hypothesize that the intervention will improve coping responses to discrimination and HIV treatment adherence.

Eligibility criteria: Inclusion Criteria:

* Age 18 years-old or older, HIV-positive, biologically male at birth and continue to identify as male, identify as Latino, report having sex with men in the past 12 months, and prescribed ART.

Exclusion Criteria:

* Being unwilling or unable to provide informed consent; having mental health problems that require immediate treatment (e.g., psychotic symptoms) or a diagnosed mental disorder that would limit ability to participate (e.g., dementia); and cognitive impairments that result in limited ability to provide informed consent.

Primary outcomes:
measure: Continuous Adherence (MEMS)
timeFrame: 4-5 and 6-7 months post-baseline
measure: Continuous Adherence (Self-report)
timeFrame: 4 and 7 months post-baseline
Secondary outcomes:
measure: Functional Coping Strategies
timeFrame: 4 and 7 months post-baseline
measure: Positive Religious Coping Strategies
timeFrame: 4 and 7 months post-baseline
measure: Dysfunctional Coping Strategies
timeFrame: 4 and 7 months post-baseline
measure: Negative Religious Coping Strategies
timeFrame: 4 and 7 months post-baseline
measure: Medical Mistrust (General)
timeFrame: 4 and 7 months post-baseline
measure: Medical Mistrust (HIV Conspiracy Beliefs)
timeFrame: 4 and 7 months post-baseline
measure: Internalized Stigma (Sexual Orientation)
timeFrame: 4 and 7 months post-baseline
measure: Internalized Stigma (HIV)
timeFrame: 4 and 7 months post-baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Bienestar Human Services, Inc.
state: California
Study officials:
affiliation: RAND
name: Laura Bogart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bogart LM, Barreras JL, Gonzalez A, Klein DJ, Marsh T, Agniel D, Pantalone DW. Pilot Randomized Controlled Trial of an Intervention to Improve Coping with Intersectional Stigma and Medication Adherence Among HIV-Positive Latinx Sexual Minority Men. AIDS Behav. 2021 Jun;25(6):1647-1660. doi: 10.1007/s10461-020-03081-z. Epub 2020 Nov 24.