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

January 16, 2024 updated by: Corina Lelutiu-Weinberger, Columbia University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
    • Ilfov
      • Bucharest, Ilfov, Romania
        • Romanian Association against AIDS (ARAS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: Comunică
Comunică is based on the Information-Motivation-Behavioral Skills (IMB) model of health behavior change, which postulates that individuals must possess the requisite information for enacting sexual health, motivation to change their HIV risk and alcohol use, and behavioral skills necessary for reducing their risk. Therefore, Comunică includes MI to provide accurate information about HIV transmission, alcohol abuse, and local GBM-affirmative health resources and build motivation to improve behavioral skills (via CBST). CBST is a therapeutic approach used in the treatment of various behavioral problems, such as alcohol abuse and depression and more recently HIV risk. CBST can help modify cognitions driving unhealthy behaviors, promote awareness of contextual triggers and unhealthy behavioral patterns, and teach coping skills to improve health. Comunică also draws upon minority stress theory recognizing that stigmatizing societal contexts compromise health behavior.
Active Comparator: Education Attention Control (EAC)
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Followback for Online Use: (Sexual behavior)
Time Frame: 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.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Timeline Followback for Online Use: (Alcohol use)
Time Frame: 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.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 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.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Beck's Anxiety Inventory (BAI)
Time Frame: 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
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Alcohol Use Disorders Identification Test (AUDIT-C)
Time Frame: 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.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV Knowledge Questionnaire
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
It is a 18-item, brief self-report measure of HIV-related knowledge. Respondents read each statements about HIV and indicate whether they think the statement is true or false, or they indicate that they "don't know." Cronbach's alpha ranges from 0.75-0.89.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Alcohol Effects Questionnaire
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
This is a 10-item scale asking about alcohol use-related knowledge (e.g., "Beer usually contains from 2-12% alcohol by volume") with responses being 0=I don't know, 1=True and 2=False. Cronbach's alpha is 0.86.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
SOCRATES Scale
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
The SOCRATES is a 19-item, self-administered instrument designed to assess client motivation to change drinking-related behavior. It is made up of three scales: Problem Recognition, Ambivalence, and Taking Steps. Respondents rate their agreement with each item on a 5-point Likert-type scale (from strongly disagree to strongly agree). Cronbach's alpha ranges from 0.88-0.0.96 across three subscales.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Decisional Balance (motivation to use condoms)
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
This 18-item scale measures one's motivation to increase condom use (e.g., "I would feel bad if my friends found out I had sex without a condom"), with response options ranging between 1=not at all to 5=extremely. Cronbach's alpha is 0.88.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Rejection Sensitivity Scale
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
It is a 14 items gay-related rejection sensitivity measure. Participants first indicated how concerned or anxious they would be that the situation occurred because of their sexual orientation. They then indicated the likelihood that the situation occurred because of their sexual orientation. Cronbach's alpha is .91.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
LGBT Victimization Scale
Time Frame: From baseline to each follow-up assessment point (4, 8, and 12 months post-training)
A 10-item measure that assesses the frequency of experiences of victimization in the previous 6 months "because you are, or were thought to be, gay, lesbian, bisexual, or transgender." Items addressed verbal threats and insults, being chased, having property damaged, and being physically or sexually assaulted. Cronbach alpha is .86.
From baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Multidimensional Scale of Perceived Social Support
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. It is rated on a seven-point Likert-type scale with scores ranging from 'very strongly disagree' (1) to 'very strongly agree' (7). The MSPSS has proven to be psychometrically sound in diverse samples and to have good internal reliability and test-retest reliability, and robust factorial validity.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Safer-Sex Self-Efficacy Questionnaire
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)

It is a 13-item scale that measures behavioral self-efficacy skills to increase condom use. Cronbach's alpha is 0.88.

Response options range from "not at all confident" to "extremely confident"
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Confidence in Reducing Alcohol Use Questionnaire
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
It is a 15-item scale that measures behavioral self-efficacy skills to reduce alcohol use. Response options are measured from 1 (not at all) to 6 (completely). Cronbach's alpha ranges from 0.79 - 0.95.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Assertiveness Scale
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
A 30-item self-report which measure assertive behaviors. The items include statements like "Most people seem to be more aggressive and assertive than I am", "When I am asked to do something, I insist upon knowing why" etc. The responses ranges from 3, very much like me to -3 very much unlike me. Scores on the assertiveness schedule can vary from +90 to -90.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
Multidimensional Measure of Sexual Minority Identity
Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)
It is a 27 items self-report that measure acceptance, concealment motivation, identity affirmation, etc. of sexual minority populations. Cronbach's alpha ranges from 0.78-0.86.
From change baseline to each follow-up assessment point (4, 8, and 12 months post-training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Mental Health (NIMH)
Yale University

Investigators

  • Principal Investigator: Corina Lelutiu-Weinberger, PhD, Columbia University
  • Principal Investigator: John E. Pachankis, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU2518
  • R01MH116829 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression, Anxiety

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe