Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03432819
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2018-01-31
Brief Title:
A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Sponsor:
RAND
Organization:
RAND
Study Overview
Official Title:
A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None