Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Risk Reduction; Depression, Anxiety; Behavior, Sex; Alcohol Abuse
• Interventions: Behavioral: Comunică; Other: Education Attention Control

• Registration Number: NCT03912753
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this research study is to provide help and support for mental health and human immunodeficiency virus (HIV) risk reduction among Romanian gay and bisexual men.

GBM will participate in this study using mobile device (phones, tablets, or laptops) and will complete several confidential surveys and 8 confidential one-hour sessions, either with a trained counselor via chat or by reading about health information. This study also involves testing for HIV, syphilis, chlamydia, and gonorrhea.

Detailed Description

This project is designed to remedy unaddressed and interlocking HIV-prevention and mental health needs among gay and bisexual men (GBM) in the Central Eastern European country of Romania, and their underpinning stigma-related mechanisms. Rampant stigma contributes to the increasing prevalence of HIV among Romanian GBM (from under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBM out-of-reach of HIV-prevention services. An mHealth pilot intervention (titled "Despre Mine. Despre Noi." (DMDN) translated as "About Me. About Us."), which reduced Romanian GBM's risk for HIV infection while also reducing depression and alcohol abuse in an initial pre-post trial, is now ready for testing in a randomized controlled trial with a large national sample in the current study, entitled Comunică (translation: Communicate).

The Comunică intervention entails eight 60-minute live chat sessions delivered by trained counselors on a mobile study platform using motivational interviewing (MI) and cognitive-behavioral skills training (CBST). First, during pre-trial (months 1-5), in collaboration with a community advisory board consisting of GBM community members, GBM-affirmative physical and mental health providers, and a technical developer, the investigators will fine-tune the Comunică intervention based on the investigators' pilot findings and evaluation interviews, and expand the original DMDN education materials for an education attention condition (EAC) that will serve as control. Second, during the intervention phase (mos 6-45), the investigators will recruit, screen, assess, and randomize GBM at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163). The conditions are content matched, and both are hosted on the study platform. While Comunică will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self-administered educational modules. Third, during the follow-up phase (mos 8-55), the investigators will assess at 4, 8, and 12 months post-baseline, in a mobile fashion identical to the baseline, the primary outcome of condomless anal sex with male partners and secondary outcomes of alcohol abuse, depression, biologic HIV/STI infection, HIV/STI testing, and psychosocial mechanisms rooted in the Information-Motivation-Behavioral Skills (IMB) model (e.g., HIV/STI knowledge, condom use self-efficacy) and minority stress theory (e.g., identity concealment, internalized homophobia).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Study Start: 2019-05-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 305

Inclusion Criteria

Gay and bisexual men (GMB) will be eligible if they report:

• Male sex at birth and current male identity;
• At least 16 years old;
• ≥ 3 acts of condomless anal sex with an HIV-positive or status-unknown male partner in the prior 3 months;
• ≥ 15 heavy drinking days in the prior 3 months, (e.g., binge drinking as defined by SAMHSA: ≥ 5 standard alcoholic drinks on five occasions per month);
• Own a mobile device (smartphone, tablet, laptop); and
• Are confirmed to be HIV-negative upon testing at study baseline.

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Exclusion Criteria

• GMB will be excluded if they report past-year: a) psychiatric hospitalization; b) psychotic and manic symptoms; or c) current mood-stabilizing or anti-psychotic medication prescription
• Any condition that, in the principal investigators' judgment, interferes with safe study participation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comunică	Comunică	Comunică is delivered over eight 60-min live chat sessions, delivered by trained psychologists, on our mHealth study platform compatible with any mobile device (laptops, smartphones).
Education Attention Control (EAC)	Education Attention Control	The EAC condition consists of eight self-administered modularized topics, content-matched with the Comunică sessions, which we have generated based on our HIV-prevention education with GBM in the US and Romania.Topics include 1) GBM identity, 2) "HIV 101," 3) HIV/STI testing, 4) alcohol and the body, 5) the role of alcohol in HIV risk, 6) HIV-status disclosure and sexual health communication, 7) finding social supports, and 8) summary. EAC participants will receive five quiz questions after each module, with correct answers in a following screen.

Primary Outcome Measures

Name	Time	Method
Timeline Followback for Online Use: (Alcohol use)	From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)	The TLFB tool will also ask participants to report on alcohol heavy use alone, and before/during sex, in the previous 30 days.
Timeline Followback for Online Use: (Sexual behavior)	From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)	TLFB assesses sexual behavior in the past month. It collects retrospective day-level data and has been validated for online self-administration. The TLFB has good test-retest reliability, convergent validity, and agreement with collateral reports for sexual behavior and alcohol use. Participants will report on daily partner type (e.g. primary, casual), type of sexual behavior (e.g. insertive anal), and condom use. Median cronbach's alpha is 0.96.

Secondary Outcome Measures

Name	Time	Method
Beck's Anxiety Inventory (BAI)	From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)	BAI is a brief self-report measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It consists of 21 items and respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). Cronbach's alpha is 0.94
Alcohol Use Disorders Identification Test (AUDIT-C)	From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)	The AUDIT-C is a 3-item screening tool use to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Participants will report on standard drinks. A score of 4 or more is considered to indicate hazardous or harmful alcohol use. Cronbach's alpha is 0.82.
Center for Epidemiologic Studies Depression Scale (CES-D)	From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)	CES-D is a self-report, standardized measure for depressive symptoms. It consists of 20-items in which respondents rate how frequently each item applied to them over the course of the past week. Ratings are based on a 4-point Likert scale ranging from 0 (rarely or none of the time \[less than 1 day\]) to 3 (most or all of the time \[5-7 days\]). Cronbach's alpha coefficients ranging from .85 to .90 across studies.

Trial Locations

Locations (1)

Romanian Association against AIDS (ARAS); 🇷🇴 Bucharest, Ilfov, Romania