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

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 300

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;
≥ 1 act of condomless anal sex with an HIV-positive or status-unknown male partner in the prior month;
≥ 2 heavy drinking days in the prior month;
Own a mobile device (smartphone, tablet, laptop); and
Are confirmed to be HIV-negative upon testing at study baseline.

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days	Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline	Timeline Followback for Online Use (TLFB), which assesses sexual behavior (condomless anal sex acts) in the past month. It collects retrospective day-level data and has been validated for online self-administration.
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days	Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline	The Timeline Followback for Online Use (TLFB) tool will also ask participants to report occasions of heavy alcohol use (5 or more drinks) alone, and before/during sex, in the previous 30 days.

Secondary Outcome Measures

Name	Time	Method
Score on Alcohol Use Disorders Identification Test (AUDIT-C)	Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline	The Alcohol Use Disorders Identification Test (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. The total score range is 0 to 12 (each item is scored 0-4), where an overall score of 4 or more is considered to indicate hazardous or harmful alcohol use. Higher scores indicate more hazardous/harmful alcohol use (i.e., a worse outcome).
Score on Center for Epidemiologic Studies Depression Scale (CES-D)	Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline	Center for Epidemiologic Studies Depression Scale (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 for each item 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)". Item scores are summed to obtain an overall score from 0 to 60, where higher scores mean more depressive symptoms (i.e., a worse outcome).
Score on Beck's Anxiety Inventory (BAI)	Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline	Beck's Anxiety Inventory (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 to each item are rated on a 4-point Likert scale and range from 0="not at all" to 3="severely". Item scores are summed to obtain an overall score from 0 to 63, where higher scores indicate more anxiety symptoms (i.e., worse outcome).

Trial Locations

Locations (1): Romanian Association against AIDS (ARAS)
🇷🇴
Bucharest, Ilfov, Romania
Romanian Association against AIDS (ARAS)
🇷🇴Bucharest, Ilfov, Romania