Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Phase: NA
Conditions: Human Immunodeficiency Virus, Risk Reduction, Alcohol Abuse, Depression, Anxiety, Behavior, Sex
Sponsor: Columbia University

 
 
 
 
 
 
Building Mobile HIV Prevention and Mental Health Support 
in Low-Resource Settings 
 
 
NCT03912753 
2/15/2025 
 
 
 

BACKGROUND 
 
Study Purpose and Rationale 
This research is designed to remedy unaddressed and interlocking HIV-prevention and 
mental health needs among gay, bisexual, and other men who have sex with men (GBMSM) 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 GBMSM (from 
under 10% in 2009 to close to 20% in 2014, by best available estimates) and keeps GBMSM out-
of-reach of HIV prevention services. The team’s mHealth pilot intervention (titled “Comunica: 
Despre Mine. Despre Noi.” [COMUNICA] translated as “About Me. About Us.”), which reduced 
US and Romanian GBMSM’s risk for HIV infection while also reducing depression and alcohol 
abuse in initial pre-post trials, is now ready for testing in a randomized controlled trial with a large 
national sample in the current study. The Comunica intervention entails eight 60-minute live chat 
sessions delivered by trained counselors on our 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 GBMSM community members, GBMSM-affirmative physical and mental health 
providers, and a technical developer, the team fine-tuned the Comunica intervention based on pilot 
findings and evaluation interviews, and expand the original Comunica education materials for an 
education attention condition that will serve as a control arm. 
Second, during the intervention phase (months 6-45), the team will recruit, screen, assess, 
and randomize GBMSM at risk for HIV infection and alcohol abuse to either the Comunica 
intervention (n=163) or education attention condition (n=163). The conditions are content 
matched, and both are hosted on the study platform. While Comunica will consist of eight weekly 
mHealth live chat sessions, the education attention control condition will consist of eight self-
administered educational modules. 
Third, during the follow-up phase (months 8-55), the team 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 (CAS) with male partners, secondary outcomes of alcohol abuse, depression, and anxiety, 
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).  
 
Research Aims & Abstracts 
Aim 1. Test the relative efficacy of the Comunica mHealth intervention compared to a 
content-matched education attention control condition in changing (a) the primary outcome: CAS 
with HIV-positive or unknown-status partners and (b) secondary outcomes: depression, anxiety, 
and alcohol abuse. Outcomes are measured at preintervention (baseline), and at 4-, 8-, and 12-
month follow-ups. 
Primary and Secondary Outcomes (Aim 1). Comunica GBMSM, compared to education 
attention control condition GBMSM, will report significantly greater changes on primary 
(decreased CAS) and secondary (decreased alcohol use, depressive symptoms, and anxiety 
symptoms) outcomes across 12 months. 
Aim 2. Test motivational and stigma-related mechanisms of intervention efficacy. 
Hypothesized motivational mechanisms include HIV/STI and alcohol-related knowledge and 
behavioral skills as well as condom-use and refraining-from-alcohol-use self-efficacy, grounded 
in the IMB model. Hypothesized minority stress mechanisms include collective self-esteem, 
internalized homophobia, identity concealment, and stigma consciousness, which are grounded in 
minority stress theory and are particularly relevant for GBMSM in high-stigma countries. 
IMB and Minority Stress Mediation Hypothesis (Aim 2). Comunica GBMSM, compared 
to education attention condition GBMSM, will report greater improvement in 1) knowledge of 
sexual health and deleterious effects of alcohol use, 2) motivation to change risk behavior and 3) 
behavioral self-efficacy to execute changes across 12 months. Comunica GBMSM, compared to 
education attention condition GBMSM, will also report significantly greater shifts in minority 
stress (e.g., attenuated internalized homophobia, identity concealment) across 12 months. 
Improvements in IMB and minority stress mechanisms will precede and statistically mediate 
intervention effects, based on our conceptual model. 
 
 
 
 

STUDY DESIGN 
 
First, in a pre-trial phase (months 1-5), in collaboration with a community advisory board 
(CAB) consisting of collaborators, gay and bisexual men, gay and bisexual men-affirmative 
physical and mental health providers, and technical developer, we will first fine-tune and pre-test 
the Comunica intervention based on pilot findings and exit interviews, and expand the preliminary 
education materials for the education attention control condition. 
Second, during the intervention phase (months 6-45), the team will recruit, screen, assess, 
and randomize gay and bisexual men at risk for HIV infection, alcohol abuse, and depression to 
either the Comunica intervention (n=163) or education attention condition (n=163). The conditions 
are content matched, and both are hosted on the study platform. Comunica consists of eight weekly 
mHealth live chat sessions; education attention condition will consist of eight self-administered 
educational modules.  
 
Eligibility 
Potential participants will be eligible if they report: 
1) Male sex at birth and current male identity 
2) Age 16 years and above 
3) At least 1 CAS act with an HIV-positive or status-unknown male partner in the prior 
month 
4) At least 1 heavy drinking day in the prior month 
5) Own a mobile device (e.g., smartphone, tablet, laptop) 
6) Planned residence in Romania for the duration of study participation (12 months) 
7) Not currently using HIV pre-exposure prophylaxis (PrEP) 
8) Confirmed to be HIV-negative upon testing at baseline 
 
Baseline (BL), 4-, 8-, and 12-month Assessments 
The project coordinator will send a link to the BL survey to all HIV-negative participants, 
and tell them that they will be contacted by their counselor after submitting the survey. The 
quarterly self-administered mobile assessments are identical, take 45 minutes to complete, have 
been validated by the Romanian pilot gay and bisexual men participants, and assess: 1) sexual 

behavior (e.g., number of CAS acts; number and types of partners; sex under the influence) and 2) 
past-3-month alcohol use; 3) depressive symptoms; 4) HIV/STI testing and other healthcare access 
(e.g., annual exams; mental health) patterns; 5) hypothesized mediators of intervention efficacy, 
including IMB model components (e.g., HIV-risk-related information, motivation, behavioral 
skills) and minority stress (e.g., outness, internalized homonegativity, collective self-worth); and 
6) demographics and psychosocial risk contexts, including intimate partner violence. Third, during 
the follow-up phase (mos 8-55), we will assess at 4, 8, and 12-mos post-baseline, in the same web-
based fashion as at baseline, the primary outcome of CAS with male partners, and secondary 
outcomes of alcohol abuse, depression, anxiety, 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, stigma consciousness). 
We hypothesize that 1) compared to gay and bisexual men in the education attention control 
arm, those randomized to the Comunica arm will report significant reductions in CAS acts, 
depression symptoms, and anxiety symptoms across the 12-month follow-up, 2) IMB and minority 
stress mechanisms will statistically mediate intervention efficacy, and 3) compared to the control 
condition, the Comunica intervention will prove cost-effective in terms of reducing depression, 
anxiety, and alcohol abuse. 
 
Intervention Content 
Comunica Content. The intervention aims to support gay and bisexual men in reducing 
their CAS act and alcohol use and improving their mental health. Comunica is delivered over eight 
60-min live chat sessions on our mHealth study platform compatible with any mobile device (e.g., 
laptops, smartphones). 
Theoretical Grounding. Comunica is based on the IMB model of health behavior change, 
which postulates that individuals must possess the requisite information on sexual health and 
alcohol, motivation to change their HIV risk and alcohol use, and behavioral skills self-efficacy to 
reduce their risk. Therefore, Comunica includes MI to provide accurate information about HIV 
transmission, alcohol abuse, and local GBMSM-affirmative health resources (e.g., HIV-testing 
sites) and build motivation to improve behavioral skills (via CBST). MI is an evidence-based form 
of person-centered therapeutic communication that privileges client values and preferences for 
change to help individuals resolve ambivalence and move toward their valued goals. Skills-

building is often a natural outcome of MI, especially for individuals who attain a high degree of 
motivation for change. CBST is a therapeutic approach used in the treatment of various behavioral 
problems, such as alcohol abuse, depression, and more recently high 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. Comunica also draws 
upon minority stress theory recognizing that stigmatizing societal contexts compromise health 
behavior. GBMSM in highly stigmatizing contexts such as Romania experience a lack of structural 
protections (e.g., national policies), institutional support (e.g., GBMSM-affirmative healthcare), 
and coping resources (e.g., social support). Thus, the CBST skills in Comunica are presented in a 
manner that acknowledges the barriers that social stigma poses to GBMSM’s health, while 
empowering them to circumvent these barriers by building self-efficacy, effective communication, 
and planful problem-solving. Safety protocols include instructions for protecting participants’ 
identities, data, and safety. 
Education Attention Control Condition. The control condition consists of eight 
modularized topics content-matched with the Comunica sessions, which we have generated based 
on the team’s HIV-prevention education with GBMSM in the US and Romania. Topics include 1) 
GBMSM 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) a summary. To maintain uniformity of information exposure across participants and 
maximize learning, each screen will be timed at a comfortable speed and participants will be unable 
to advance to the next screen prior to the set time limit. Control participants will receive five quiz 
questions after each module, with correct answers on a subsequent screen.