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

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ClinicalTrials.gov Identifier: NCT03912753
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Corina Lelutiu-Weinberger, Rutgers University

Brief Summary:
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 (mos 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).

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Risk Reduction Alcohol Abuse Depression, Anxiety Behavior, Sex Behavioral: Comunică Other: Education Attention Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: We 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). The conditions are content matched, and both are hosted on our study platform. While Comunică will consist of eight weekly mHealth live chat sessions, EAC will consist of eight self-administered educational modules. We we will assess at baseline, and 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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 three months. 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 sexand alcohol use. Participants will report on daily partner type (e.g. primary), type of sexual behavior (e.g. insertive anal), and condom use. Median cronbach's alpha is 0.96.

  2. 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 90 days.


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) ]
    AUDIT is a 10-item screening tool use to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Participants will report on standard drinks. A score of 8 or more is considered to indicate hazardous or harmful alcohol use. Cronbach's alpha is 0.82.

  2. 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.

  3. 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


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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. . Cronbach's alpha ranges from 0.79 - 0.95.

  7. 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.

  8. Sexual Orientation Concealment Scale [ Time Frame: From change baseline to each follow-up assessment point (4, 8, and 12 months post-training) ]
    It is a 6-item measure designed to assess lesbian, gay, and bisexual (LGB) individual's active concealment of their sexual minority status. Items were derived from literature on sexual orientation identity management and include items reflecting use of avoidance strategies (i.e., evading circumstances that would implicate one as LGB) and counterfeiting strategies (i.e., constructing a false guise of heterosexuality). Respondents were asked to "rate each item to complete the following phrase: In the last 2 weeks, I have . . ." using a fully anchored rating scale (1 not at all, 2 a little bit, 3 somewhat, 4 very much, 5 all the time).

  9. 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 statamenst 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological males at birth who currently identify as male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gay and bisexual men will be eligible if they report: 1) male sex at birth and current male identity; 2) ≥ age 16; 3) ≥ 3 acts of condomless anal sex with an HIV-positive or status-unknown male partner in the prior 3 months; 4) ≥ 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); 5) own a mobile device (smartphone, tablet, laptop); and 6) are confirmed to be HIV-negative upon testing at study baseline.

Exclusion Criteria:

  • As severe mental illness poses barriers to participation, 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. Lastly, we will exclude participants based on any condition that, in the principal investigators' judgment, interferes with safe study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912753


Contacts
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Contact: Corina Lelutiu-Weinberger, PhD 973-972-2093 cl1148@sn.rutgers.edu
Contact: John E Pachankis, PhD 203-785-3710 john.pachankis@yale.edu

Locations
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Romania
Romanian Association against AIDS (ARAS) Recruiting
Bucharest, Ilfov, Romania
Contact: Mihai Lixandru    +40213190771    mihai.lixandru@arasnet.ro   
Sponsors and Collaborators
Rutgers University
Yale University
Investigators
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Principal Investigator: Corina Lelutiu-Weinberger, PhD Rutgers University
Principal Investigator: John E Pachankis, PhD Yale University

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Responsible Party: Corina Lelutiu-Weinberger, Assistant Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT03912753     History of Changes
Other Study ID Numbers: R01MH116829 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Alcoholism
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders