Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05123274 |
| Other study ID # |
R34MH125715 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
November 30, 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Medical College of Wisconsin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The intervention study will recruit 100 out-of-care HIV+ men who have sex with men in online
and in community settings located throughout St. Petersburg, Russia. After completing
baseline assessments, participants will be randomized to either an individual care counseling
(ICC) comparison condition or ICC plus a social support mobilization (SSM) intervention. In
each intervention, participants will attend five main and two booster sessions that
underscore the benefits of medical care engagement, counter the effects of internalized
intersectional stigma and promote resilience, and help participants develop and mobilize
social resources supportive of HIV care. Support mobilization will begin by assisting
participants develop care-supportive bonds with other group members, friends who are also
living with HIV, and connections made with LGBT and other non-governmental organizations.
They will also be guided in developing and expanding supportive links with affirmative
friends, family members, and other resources. In this way, the intervention will bolster
care-related social support resources, resilience, and feelings of self-worth. Assessments
administered at baseline will be repeated 6 and 12 months post-intervention, and in-depth
followup interviews will be conducted with a subset of 20 participants to elicit feedback
about the intervention experience. The study will investigate whether the SSM intervention
will produce greater preliminary evidence of benefit on the primary outcome of medical care
attendance in the past 6 months and on secondary outcomes of having undetectable viral load,
ART adherence, and psychosocial well-being.
Description:
100 HIV+ men who have sex with men (MSM) will be recruited and will complete an individual
baseline assessment of HIV medical care engagement, adherence if prescribed antiretroviral
medications, substance use, psychosocial well-being, social resources, and a blood draw for
viral load testing. At the end of the baseline visit, participants will receive counseling
about HIV care as well as referral for medical care and other services. The 100 participants
will be randomized to one of two conditions. 50 participants will receive only the counseling
provided during the baseline visit (ICC Comparison Group). The 50 participants assigned to
the experimental condition will additionally receive the Social Support Mobilization (SSM)
intervention being tested in the research. A subset of 20 intervention attendees will
participate in in-depth followup interviews to elicit their feedback about the intervention
experience. All study participants will complete 6- and 12-month followup assessments with
measures administered at baseline. If there is evidence of intervention benefit, members of
the former comparison condition will be offered the intervention after the final followup
point as an ethical service.
Participant Recruitment
St. Petersburg is a large city with a population of 4.5 million residents. Participants will
be recruited from:
1. venues such as support groups and events held by non-governmental organizations;
2. virtual spaces such as HIV+ and gay-oriented online forums, boards, and social media
sites; and
3. through community announcements in venues where MSM meet.
The use of multiple modalities for recruitment in a large city will result in a sample of
HIV+ MSM with minimal potential for overlap. Interested individuals will be asked to contact
the study office by telephone or social media. Ineligible persons will be referred for HIV
medical and other services. Individuals whose HIV status is not confirmed by baseline testing
will be excluded.
Baseline Assessment Procedures and Measures. All study activities will take place at a
community-based office located in central St. Petersburg, easily accessible by public
transportation. Eligible participants will provide written informed consent at the start of
the 90-minute individual baseline assessment session.
Demographic characteristics and health history. Participants will provide information about
their demographic characteristics (age, income, education, and relationship status) and
HIV-related health history (length of HIV+ serostatus knowledge and HIV care, treatment, and
ART history).
HIV care engagement, appointment keeping, and ART adherence. Respondents will be asked how
many HIV-related medical treatment appointments they attended in the past 6 months; how many
appointments were scheduled, kept, or missed; and date of their most recent appointment.
Russian HIV care providers give patients a document that specifies the date of their most
recent medical visit and test results. To verify treatment attendance, participants will be
asked to bring the document to their assessment visit. For participants prescribed
anti-retroviral therapy, two adherence measures will be administered: (1) the Visual Analog
Scale (VAS) completed to indicate percentage of medication doses taken as prescribed in the
past month, shown valid for measuring adherence; and (2) the HRSA SPNS ART Adherence Scale, a
measure with well-established reliability and validity.
HIV viral load testing. A blood sample drawn by the project's physician or nurse will be
tested to verify serostatus and determine HIV viral load, considered undetectable if <200
copies/ml., a cutoff based on prior research findings. Viral load testing biologically
corroborates care and adherence self-reports.
Measures of medication-taking readiness and self-efficacy. Participants not on
anti-retroviral medication therapy will be administered 9 items of the HIV Medication
Readiness Scale (sample item: "How ready are you to accept the idea of taking HIV pills for a
long time?"). Participants ever prescribed anti-retroviral medication therapy will complete
the HIV Medication-Taking Self-Efficacy Scale that consists of two subscales, Self-Efficacy
Beliefs (sample item: "How confident are you in your ability to take HIV medication at
correct intervals?") and Outcome Expectancies (sample item: "Taking HIV medication will allow
you to live a long life").
Scales of psychosocial well-being. To determine if the planned intervention benefits
participants' psychosocial adjustment, participants will complete the Social Provisions Scale
to measure perceived social supports; the Center for Epidemiological Studies-Depression to
measure depression; and the State Anxiety Inventory. Stigma associated with HIV and with
same-sex orientation will also be measured. The HIV Stigma Scale assesses overall HIV stigma
and personalized stigma, disclosure concerns, negative self-image, and concern with public
attitudes. The Homosexuality-Related Stigma Scale measures experienced and internalized
stigma associated with same-sex behavior.
Transmission risk behavior and substance use. The level of alcohol use and problem drinking
will be assessed by presenting a list of alcohol and illicit drugs commonly used in Russia
and asking participants on how many days in the past month each was used and how much was
used on the day of greatest use. Participants reporting drug injection will be asked about
type of drug, frequency of injection, and use of clean needles. Participants will report on
their number and types of male and female sex partners in the past 3 months, frequency of
condomless intercourse, and HIV concordance by partner.
Assessment of social resources. Levels and change over time in participants' number and
quality of supportive relationships will be measured using the Social Network Map originally
developed and validated, and shown to have strong psychometric characteristics by Tracy and
Whittaker. Content will be adapted to also assess HIV care support. Respondents list, by
first name and last name initial, individuals in their lives who provide emotional support,
practical assistance, financial assistance, socializing and advice/guidance. The Social
Network Map yields a total network size score as well as scores for network size in each of
the domain-specific areas. Use of this instrument will determine whether the intervention
produces change in number of social resources over time and in the perceived quality of
support from them.
Individual care-related counseling session. After completing all measures, each participant
will receive a 20-minute individual counseling session focused on HIV medical care conducted
by project staff who hold master's degrees in counseling-related fields carefully trained to
protocol.
Sessions will always convey that effective HIV treatment is now available at no cost,
protects health, and that most people living with HIV and in treatment can lead long and
healthy lives. Referral will be made and assistance provided in accessing LGBT-friendly HIV
medical care, mental health, substance abuse, and other services.
Randomization of Participants to Study Conditions. Following baseline data collection, the
participants will be randomly allocated in equal numbers by the study biostatistician to one
of the two study conditions.
Intervention Procedures.
Individual care counseling (ICC)-only comparison condition. All study participants will
receive the baseline individual counseling session described above. This constitutes the only
intervention provided to comparison condition participants.
Social Support Mobilization (SSM) Intervention. The study's intervention is based on the
hypothesis that participants who have social supports will obtain better outcomes. Thus, the
intervention will teach and guide participants in identifying, accessing, and mobilizing
social supports.
Intervention Conduct. Groups of 8 to 10 participants will attend five weekly sessions
followed by booster sessions to sustain momentum two and again four weeks after the main
intervention. Each session will last for about 2-1/2 hours and be led by an experienced
2-member team of facilitators who hold Master's degrees in behavioral/social sciences and are
experienced in facilitating HIV-related group sessions with MSM. Staff who conduct
intervention sessions will always be different than those who recruit, consent, and assess
participants. Groups will be close-ended and scheduled at a time convenient for all members.
The same group of participants will attend the full series of intervention sessions together
in order to build mutual supports and cohesion. Individuals who miss a session will be
offered the opportunity to attend a make-up session.
The intervention has three inter-related objectives: (1) ensuring that participants
understand that viral suppression through ART maintains health and protects others; (2)
increasing resilience and feelings of self-worth; and (3) guiding participants in
identifying, accessing, and mobilizing social resources for both general psychosocial support
and also specific supports for HIV care. For individuals who have potential supports in their
social environment, the intervention will seek to mobilize or increase the frequency and
quality of interactions with them. For MSM who are presently socially isolated or whose
social resources are not supportive of HIV care, the intervention will help to build new
social ties with potentially supportive life figures.
The intervention will assist participants in mobilizing mutual supports for HIV care with
other session participants, with other HIV+ friends, and through involvement in the programs,
activities, and message boards of LGBT and community advocacy organizations in St.
Petersburg. Bonds formed through these channels are likely to be accepting, affirmative, and
nonjudgmental. Participants will discuss, practice, and plan ways to offer-and ways to
gain-care-related informational supports (such as sharing information about care providers
known to be affirmative and accessible), emotional supports (helping one another cope with
life stressors), and tangible supports (helping one another get to clinic appointments).
Intervention sessions will link group members to mutually support one another in care-related
strategies, and will assign participants to reach out to other friends or to the programs of
LGBT organizations where they can link with others for care supports. Beyond supports
specific to HIV care engagement, the intervention will also seek to build social resources
for general psychosocial well-being and for social integration with persons believed to be
supportive of health and self-esteem.
Sessions will employ interactive discussion, skills-building exercises, group problem
solving, and goal-setting for social support mobilization and for mutual care-related
supports. Week-by-week, participants will be asked to share with one another challenges and
care barriers they face, life concerns they have, steps taken toward HIV care engagement, and
social connections made since the last session. In these ways, the intervention will help
participants develop and mobilize social capital that can directly support HIV care
engagement and also strengthen psychosocial well-being.
All participants who received the SSM intervention will complete measures eliciting
intervention feedback at the end of the final booster session. In addition, 40% of
participants will be randomly selected for in-depth interviews to provide feedback and
discuss their experience in the intervention and perceptions about how it can be improved.
The interviews will be conducted immediately after the intervention ends so that
participants' memories will be fresh. The interviews will seek feedback on all aspects of the
intervention including its most and least useful format, content and interactive techniques,
and outcomes of social resource mobilization efforts. Interviews will delve into reactions of
others to participants' social resource mobilization efforts. Interviews will be conducted by
experienced in-depth interviewers uninvolved in intervention delivery, will be recorded, and
will be thematically analyzed.
Followup Assessment Procedures. Participants will be followed at points 6 and 12 months after
the final main intervention session with assessments that include all behavioral measures
administered at baseline as well as viral load testing. Followups will also measure how often
in the past month the participant talked with friends about HIV care topics. These questions
will determine whether there were changes over time in care-supportive talk among
participants across the study conditions.
