HIVNCT02167828
Increasing Social Support to Improve HIV Care Engagement and Adherence in St. Petersburg, Russia
A study testing Social Support in people with HIV and AIDS, run by Medical College of Wisconsin at 2 sites in 2 countries.
Trial summary
Prior research has documented serious health, mental health, and social-behavioral issues among people living with HIV (PLH) in St. Petersburg. The investigators have established that PLH are clustered in friendship groups with other HIV+ persons and that an intervention delivered to groups composed of HIV+ men who… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2014to 8 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Self-report as being HIV-positive
- Except for initial seeds, must be named by an already-enrolled participant as an HIV-positive friend
- Do not plan to move from the St. Petersburg area for the next 12 months
- Able to provide written informed consent and do not exhibit severe alcohol intoxication, drug use impairment, or acute psychiatric impairment.
Who cannot join
- Age 17 or younger
- Self-report as HIV-negative
- Not named as an HIV-positive friend by an already-enrolled participant
- Plans to move from the St. Petersburg area in the next 12 months
- Exhibit severe alcohol intoxication, drug use impairment, or acute psychiatric impairment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Center for AIDS Intervention Research, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Increasing Social Support to Improve HIV Care Engagement and Adherence
Prior research has documented serious health, mental health, and social-behavioral issues among people living with HIV (PLH) in St. Petersburg. The investigators have established that PLH are clustered in friendship groups with other HIV+ persons and that an intervention delivered to groups composed of HIV+ men who have sex with men (MSM) who were friends in real life reduced mental health distress more than individual counseling. Specific aims of the collaborative mixed-methods, qualitative/ quantitative research are to: (1) identify facilitators and barriers of medical care attendance and ART adherence among PLH in St. Petersburg; (2) integrate these data into an intervention designed to increase HIV care attendance, retention, and adherence; (3) carry out a test-of-concept pilot study that recruits groups of PLH friends and delivers an intervention to intact PLH friendship groups to encourage mutual social support for attending medical appointments and adhering to HIV care; and (4) evaluate the effects of the intervention on both behavioral and biological measures, including viral load. These specific aims will be achieved by research carried out in two phases:
In Phase I, we will conduct in-depth interviews with 60 PLH and key informants in St. Petersburg purposively selected to include HIV+ persons in and not in medical care, adherent or not adherent to ART, and including men and women representing diverse exposure risks. In-depth interviews will be analyzed to identify factors associated with attending or not attending care and adhering or not adhering to ART, as well as identifying how HIV+ friends can support one another in HIV care entry, retention, and adherence.
In Phase II, the investigators will undertake a randomized intervention pilot study in which 20 groups of PLH friends are recruited by enrolling a PLH seed who is not reliably in care or is ART nonadherent and then recruiting all friends known by the seed to also be HIV+. A 7-session group intervention will be undertaken with all members of the friendship groups in the experimental condition to increase care and adherence-related social support, problem-solving, and mutual assistance for care. Baseline to 6-month followup data will determine whether the intervention produces greater improvement than found in the comparison group in care attendance and treatment adherence, improved mental health, lower substance use, and lower HIV viral load.
- Being tested
- Social Support
- Keywords
- HIV, AIDS, treatment adherence, social network
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social SupportBehavioural
Also called Social Network Training
| Study group | Role | What they receive |
|---|---|---|
| Social Support | Experimental | Participants will be trained to give one another ongoing, theory-based but personally-tailored advice, recommendations, and support to encourage entry to HIV medical care, remaining in care, and adhering to medication regimens when they are prescribed. The intervention's intent is to increase mutual support, positive attitudes, intentions, plans, and collective self-efficacy for care engagement. Receives: Behavioral: Social Support |
| No Intervention | No intervention | Participants in this arm will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Medical Appointments Attended
measure--through self-report--the number of medical appointments each participant attends in a six-month period.
Measured: 6 months
Secondary outcomes (2)
Number of Prescribed Antiretroviral Medication Doses Taken
measure--through self-report--the number of medication doses each participant takes in a six-month sample.
Measured: 6 months
CD4 Level
Viral load (i.e., CD4 level) in each participant will be measured via blood test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completion8 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jeffrey A. Kelly, PhD, Principal investigator, Medical College of WisconsinYuri A. Amirkhanian, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167828
- Sponsor's protocol ID
- PRO00021451
- Other IDs
- R21MH102193
- Status last verified
- Oct 2019
- First submitted
- 1 May 2014
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Social Support to Improve HIV Care Engagement and Adherence
- ClinicalTrials.gov ID
- NCT02167828
- Acronym / sponsor ID
- PRO00021451
- Keywords
- HIV, AIDS, treatment adherence, social network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prior research has documented serious health, mental health, and social-behavioral issues among people living with HIV (PLH) in St. Petersburg. The investigators have established that PLH are clustered in friendship groups with other HIV+ persons and that an intervention delivered to groups composed of HIV+ men who have sex with men (MSM) who were friends in real life reduced mental health distress more than individual counseling. Specific aims of the collaborative mixed-methods, qualitative/ quantitative research are to: (1) identify facilitators and barriers of medical care attendance and ART adherence among PLH in St. Petersburg; (2) integrate these data into an intervention designed to increase HIV care attendance, retention, and adherence; (3) carry out a test-of-concept pilot study that recruits groups of PLH friends and delivers an intervention to intact PLH friendship groups to encourage mutual social support for attending medical appointments and adhering to HIV care; and (4) evaluate the effects of the intervention on both behavioral and biological measures, including viral load. These specific aims will be achieved by research carried out in two phases:
In Phase I, we will conduct in-depth interviews with 60 PLH and key informants in St. Petersburg purposively selected to include HIV+ persons in and not in medical care, adherent or not adherent to ART, and including men and women representing diverse exposure risks. In-depth interviews will be analyzed to identify factors associated with attending or not attending care and adhering or not adhering to ART, as well as identifying how HIV+ friends can support one another in HIV care entry, retention, and adherence.
In Phase II, the investigators will undertake a randomized intervention pilot study in which 20 groups of PLH friends are recruited by enrolling a PLH seed who is not reliably in care or is ART nonadherent and then recruiting all friends known by the seed to also be HIV+. A 7-session group intervention will be undertaken with all members of the friendship groups in the experimental condition to increase care and adherence-related social support, problem-solving, and mutual assistance for care. Baseline to 6-month followup data will determine whether the intervention produces greater improvement than found in the comparison group in care attendance and treatment adherence, improved mental health, lower substance use, and lower HIV viral load.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Support | Experimental | Behavioral: Social SupportParticipants will be trained to give one another ongoing, theory-based but personally-tailored advice, recommendations, and support to encourage entry to HIV medical care, remaining in care, and adhering to medication regimens when they are prescribed. The intervention's intent is to increase mutual support, positive attitudes, intentions, plans, and collective self-efficacy for care engagement. |
| No Intervention | No intervention | –Participants in this arm will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Self-report as being HIV-positive
- Except for initial seeds, must be named by an already-enrolled participant as an HIV-positive friend
- Do not plan to move from the St. Petersburg area for the next 12 months
- Able to provide written informed consent and do not exhibit severe alcohol intoxication, drug use impairment, or acute psychiatric impairment.
Key exclusion criteria (5 listed)
- Age 17 or younger
- Self-report as HIV-negative
- Not named as an HIV-positive friend by an already-enrolled participant
- Plans to move from the St. Petersburg area in the next 12 months
- Exhibit severe alcohol intoxication, drug use impairment, or acute psychiatric impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social SupportAlso: Social Network Training | Behavioural | Social Support |
Primary outcome
Number of Medical Appointments Attended
Time frame: 6 months
measure--through self-report--the number of medical appointments each participant attends in a six-month period.
2 secondary outcomes
Number of Prescribed Antiretroviral Medication Doses Taken
Time frame: 6 months
CD4 Level
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A. Kelly, PhD principal investigator
Medical College of Wisconsin
Yuri A. Amirkhanian, PhD principal investigator
Medical College of Wisconsin
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Support in people with HIV and AIDS, run by Medical College of Wisconsin at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Medical Appointments Attended (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.