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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03912753
• Other study ID #: AAAU2518
• Secondary ID: R01MH116829
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 305
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Abuse
• Alcoholism
• Behavior, Sex
• Depression, Anxiety
• HIV Infections
• Human Immunodeficiency Virus
• Risk Reduction

Intervention

Behavioral:
• Comunica
Comunica 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, Comunica 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. Comunica also draws upon minority stress theory recognizing that stigmatizing societal contexts compromise health behavior.

Other:
• Education Attention Control
The EAC condition consists of eight self-administered modularized topics, content-matched with the Comunica sessions, which we have generated based on our HIV-prevention education with GBM in the US and Romania.

Locations

Country	Name	City	State
Romania	Romanian Association against AIDS (ARAS)	Bucharest	Ilfov

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH), Yale University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV Knowledge Questionnaire	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)
Other	Alcohol Effects Questionnaire	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)
Other	SOCRATES Scale	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)
Other	Decisional Balance (motivation to use condoms)	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)
Other	Safer-Sex Self-Efficacy Questionnaire	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)
Other	Confidence in Reducing Alcohol Use Questionnaire	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)
Other	Rejection Sensitivity Scale	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)
Other	Assertiveness Scale	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)
Other	Multidimensional Measure of Sexual Minority Identity	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)
Other	LGBT Victimization Scale	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)
Other	Multidimensional Scale of Perceived Social Support	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)
Primary	Timeline Followback for Online Use: (Sexual behavior)	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)
Primary	Timeline Followback for Online Use: (Alcohol use)	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	Alcohol Use Disorders Identification Test (AUDIT-C)	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)
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	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)
Secondary	Beck's Anxiety Inventory (BAI)	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)