Clinical trial NCT03912753: Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Official title: Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Risk Reduction
Alcohol Abuse
Depression, Anxiety
Behavior, Sex
Keywords: HIV
Syphilis
Chlamydia
Gonorrhea
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Yale University
name: National Institute of Mental Health (NIMH)
First posted: 2019-04-11
Enrollment: 305
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will recruit, screen, assess, and randomize gay and bisexual men at risk for HIV infection and alcohol abuse to either the Comunică intervention (n=163) or EAC (n=163).
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Timeline Followback for Online Use: (Sexual behavior)
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Timeline Followback for Online Use: (Alcohol use)
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Beck's Anxiety Inventory (BAI)
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Other outcomes:
measure: HIV Knowledge Questionnaire
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Alcohol Effects Questionnaire
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: SOCRATES Scale
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Decisional Balance (motivation to use condoms)
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Safer-Sex Self-Efficacy Questionnaire
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Confidence in Reducing Alcohol Use Questionnaire
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Rejection Sensitivity Scale
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Assertiveness Scale
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Multidimensional Measure of Sexual Minority Identity
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: LGBT Victimization Scale
timeFrame: From baseline to each follow-up assessment point (4, 8, and 12 months post-training)
measure: Multidimensional Scale of Perceived Social Support
timeFrame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Locations:
city: Bucharest
country: Romania
facility: Romanian Association against AIDS (ARAS)
state: Ilfov
Study officials:
affiliation: Columbia University
name: Corina Lelutiu-Weinberger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: John E. Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
References: