Human Immunodeficiency VirusNCT03157258
Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care
A study testing Social Network Training and Single Care-Related Counseling Session and Referral to Care in people with Human Immunodeficiency Virus and HIV/AIDS, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
People living with HIV infection (PLH) are clustered in friendship groups with other HIV+ persons, and an intervention delivered to all members of PLH social networks allows HIV+ people who are friends in day-to-day life to provide one another with support for entering, remaining, and adhering to HIV medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, HIV/AIDS
- What is being tested?
- Social Network Training and Single Care-Related Counseling Session and Referral to Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 30 Jun 2022
- 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, with positive HIV status confirmed in study-provided testing;
- Except for initial seeds, must be named by an already-enrolled participant as a PLH friend; and
- Do not plan to move from the St. Petersburg, Russia, area for the next 18 months.
Who cannot join
- Age 17 or younger;
- Self-report as HIV-negative or HIV-positive serostatus is not confirmed by testing;
- Not be named as a PLH friend by an already-enrolled participant; and
- Intend to move from the St. Petersburg, Russia, area during the next 18 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53202
About this study
People living with HIV infection (PLH) are clustered in friendship groups with other HIV+ persons, and an intervention delivered to all members of PLH social networks allows HIV+ people who are friends in day-to-day life to provide one another with support for entering, remaining, and adhering to HIV medical care. Moreover, an intervention delivered to groups attended by HIV+ persons who are friends increases HIV medical care engagement and decreases problem drinking more than individual counseling, probably because the network intervention harnessed mutual peer social support among friends who share the same HIV status, face similar coping issues, and interact together in day-to-day life. The planned research will be conducted in two phases in St. Petersburg, Russia.
Read the detailed description
Phase I of the planned research will be the conduct of in-depth interviews with 30 HIV+ persons not in medical care or not adherent to anti-retroviral therapy (ART) regimens, including men and women representing diverse exposure risks (drug use, men who have sex with men, and heterosexual transmission). Interviews will elicit information on ways in which HIV-positive friends can support one another in HIV care entry, retention, and adherence; types of support from PLH friends that would best support treatment engagement; and how peer supports can lessen the negative effects of substance use on care engagement.
Phase 2 will recruit 48 out-of-care or ART nonadherent HIV+ individuals from community settings in St. Petersburg, Russia. These individuals, who are referred to as "network seeds," will invite their HIV+ friends, who will in turn invite their own HIV+ friends into the study, creating a sample of 48 networks (expected n=288, 6 members/network x 48 networks). Following baseline assessment of care engagement, ART adherence, treatment attitudes, psychosocial distress, substance use, and CD4+ and viral load, 24 networks (n=144 participants) will be randomized to an intervention condition and 24 networks (n=144) to the comparison condition. All members of each intervention condition network will together attend a 4-session intervention to strengthen attitudes, intentions, and skills for entering, remaining, and adhering to HIV medical care. Because participants will attend sessions with other individuals who are their own friends in day-to-day life, the intervention will build and increase mutual social support within each network for HIV care and adherence. Peer champions identified in each intervention network will attend 3 additional sessions in which they are guided to reinforce and help to sustain friends' medical care engagement. Intervention outcomes will be determined by baseline to 6- and 12-month followup change on primary measures of participant attendance at HIV medical care visits, adherence to ART regimens, and viral load as well as secondary measures of alcohol use, drug use, sexual risk behavior, treatment attitudes, and psychosocial distress.
- Conditions
- Human Immunodeficiency Virus, HIV/AIDS
- Being tested
- Social Network Training, Single Care-Related Counseling Session and Referral to Care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Network TrainingBehavioural
Members of HIV+ social networks randomized to this arm will be trained to endorse compliance with medical guidelines and adherence to medical treatment regimens to their friends.
Single Care-Related Counseling Session and Referral to CareBehavioural
Members of HIV+ social networks randomized to this arm will attend a single, brief care-related counseling session and referral to care at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Social Network Endorsement | Experimental | All participants in this arm will receive two intervention elements: (1) they will receive a brief single care-related counseling session and referral to HIV medical care upon enrollment; and (2) all members of the HIV+ social networks will attend a multi-session group intervention during which they will be trained to deliver messages endorsing compliance with medical guidelines and adherence to medical treatment regimens to friends. Additionally, these leaders will be trained how to deliver effective messages. Receives: Behavioral: Social Network Training |
| HIV Counseling and Referral to Care | Active comparator | All study participants will receive a brief single care-related counseling session and referral to HIV medical care at baseline. Receives: Behavioral: Single Care-Related Counseling Session and Referral to Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load values
Change in HIV viral load values at baseline will be compared with HIV viral load values determined at 6 months post-intervention and 12 months post-intervention.
Measured: 0 months; 6 months; 12 months
HIV medical care visits
Change in the number of self-reported HIV medical care visits during the prior six months, comparing the number of visits reported at baseline to the number reported at six and twelve months at post-intervention followup assessments.
Measured: 0 months; 6 months; 12 months
Antiretroviral medication adherence
Change in medication adherence during the past 30 days (as measured by the visual analogue scale; J.C. Walsh, et al, 2002), comparing the adherence percentage reported at baseline to the adherence percentage reported at the six and twelve month postintervention followup assessments.
Measured: 0 months; 6 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start8 Jun 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- St. Petersburg State Pavlov Medical University
- Responsible party
- Principal investigator, Yuri A. Amirkhanian, PhD, Medical College of Wisconsin
- Investigators
- Yuri A. Amirkhanian, PhD, Principal investigator, Medical College of WisconsinJeffrey A. Kelly, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157258
- Sponsor's protocol ID
- PRO28750
- Status last verified
- Feb 2023
- First submitted
- 9 May 2017
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Intervention to Engage Community PLH to Engage in HIV Medical Care
- ClinicalTrials.gov ID
- NCT03157258
- Acronym / sponsor ID
- PRO28750
- Conditions
- Human Immunodeficiency Virus, HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- St. Petersburg State Pavlov Medical University
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
People living with HIV infection (PLH) are clustered in friendship groups with other HIV+ persons, and an intervention delivered to all members of PLH social networks allows HIV+ people who are friends in day-to-day life to provide one another with support for entering, remaining, and adhering to HIV medical care. Moreover, an intervention delivered to groups attended by HIV+ persons who are friends increases HIV medical care engagement and decreases problem drinking more than individual counseling, probably because the network intervention harnessed mutual peer social support among friends who share the same HIV status, face similar coping issues, and interact together in day-to-day life. The planned research will be conducted in two phases in St. Petersburg, Russia.
Detailed description
Phase I of the planned research will be the conduct of in-depth interviews with 30 HIV+ persons not in medical care or not adherent to anti-retroviral therapy (ART) regimens, including men and women representing diverse exposure risks (drug use, men who have sex with men, and heterosexual transmission). Interviews will elicit information on ways in which HIV-positive friends can support one another in HIV care entry, retention, and adherence; types of support from PLH friends that would best support treatment engagement; and how peer supports can lessen the negative effects of substance use on care engagement.
Phase 2 will recruit 48 out-of-care or ART nonadherent HIV+ individuals from community settings in St. Petersburg, Russia. These individuals, who are referred to as "network seeds," will invite their HIV+ friends, who will in turn invite their own HIV+ friends into the study, creating a sample of 48 networks (expected n=288, 6 members/network x 48 networks). Following baseline assessment of care engagement, ART adherence, treatment attitudes, psychosocial distress, substance use, and CD4+ and viral load, 24 networks (n=144 participants) will be randomized to an intervention condition and 24 networks (n=144) to the comparison condition. All members of each intervention condition network will together attend a 4-session intervention to strengthen attitudes, intentions, and skills for entering, remaining, and adhering to HIV medical care. Because participants will attend sessions with other individuals who are their own friends in day-to-day life, the intervention will build and increase mutual social support within each network for HIV care and adherence. Peer champions identified in each intervention network will attend 3 additional sessions in which they are guided to reinforce and help to sustain friends' medical care engagement. Intervention outcomes will be determined by baseline to 6- and 12-month followup change on primary measures of participant attendance at HIV medical care visits, adherence to ART regimens, and viral load as well as secondary measures of alcohol use, drug use, sexual risk behavior, treatment attitudes, and psychosocial distress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Network Endorsement | Experimental | Behavioral: Social Network TrainingAll participants in this arm will receive two intervention elements: (1) they will receive a brief single care-related counseling session and referral to HIV medical care upon enrollment; and (2) all members of the HIV+ social networks will attend a multi-session group intervention during which they will be trained to deliver messages endorsing compliance with medical guidelines and adherence to medical treatment regimens to friends. Additionally, these leaders will be trained how to deliver effective messages. |
| HIV Counseling and Referral to Care | Active comparator | Behavioral: Single Care-Related Counseling Session and Referral to CareAll study participants will receive a brief single care-related counseling session and referral to HIV medical care at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older;
- Self-report as being HIV-positive, with positive HIV status confirmed in study-provided testing;
- Except for initial seeds, must be named by an already-enrolled participant as a PLH friend; and
- Do not plan to move from the St. Petersburg, Russia, area for the next 18 months.
Key exclusion criteria (4 listed)
- Age 17 or younger;
- Self-report as HIV-negative or HIV-positive serostatus is not confirmed by testing;
- Not be named as a PLH friend by an already-enrolled participant; and
- Intend to move from the St. Petersburg, Russia, area during the next 18 months.
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 Network TrainingMembers of HIV+ social networks randomized to this arm will be trained to endorse compliance with medical guidelines and adherence to medical treatment regimens to their friends. | Behavioural | Social Network Endorsement |
| Single Care-Related Counseling Session and Referral to CareMembers of HIV+ social networks randomized to this arm will attend a single, brief care-related counseling session and referral to care at baseline. | Behavioural | HIV Counseling and Referral to Care |
Primary outcome
HIV viral load values
Time frame: 0 months; 6 months; 12 months
Change in HIV viral load values at baseline will be compared with HIV viral load values determined at 6 months post-intervention and 12 months post-intervention.
HIV medical care visits
Time frame: 0 months; 6 months; 12 months
Change in the number of self-reported HIV medical care visits during the prior six months, comparing the number of visits reported at baseline to the number reported at six and twelve months at post-intervention followup assessments.
Antiretroviral medication adherence
Time frame: 0 months; 6 months; 12 months
Change in medication adherence during the past 30 days (as measured by the visual analogue scale; J.C. Walsh, et al, 2002), comparing the adherence percentage reported at baseline to the adherence percentage reported at the six and twelve month postintervention followup assessments.
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 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Yuri A. Amirkhanian, PhD principal investigator
Medical College of Wisconsin
Jeffrey A. Kelly, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Network Training and Single Care-Related Counseling Session and Referral to Care in people with Human Immunodeficiency Virus and HIV/AIDS, run by Medical College of Wisconsin at 1 site in United States.
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 4 inclusion and 4 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
HIV viral load values (time frame: 0 months; 6 months; 12 months). The study lists 3 primary outcomes in all. 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 14 Jan 2026.