Adherence, PatientNCT03109743
Group Clinical Visit Adherence Intervention for HIV+ Women of Color
A study testing Sisters-GPS: Group Clinical Visits in people with Adherence, Patient and HIV/AIDS, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads (VL). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence, Patient, HIV/AIDS, Group Meetings
- What is being tested?
- Sisters-GPS: Group Clinical Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2017to 7 Dec 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-positive
- Cis gender women (assigned female sex at birth and current identifies as female)
- ≥ 18 years old
- English proficiency
- At least one visit to community health center where received HIV primary care within the last 12 months
- Self-reported ARV adherence <100% in the previous 30 days
Show all 10Show fewer
- Most recent HIV viral load in last 12 months detectable
- Prescribed HIV medications for at least 16 weeks prior to detectable HIV viral load
- Currently prescribed HIV medications (i.e., current active HIV medication prescription in electronic medical record or pharmacy)
- Able to attend most/all group visits
Who cannot join
- Untreated severe mental illness including major depressive disorder, bipolar disorder, schizophrenia, psychosis, or current suicidal ideation.
- Acute intoxication
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Development and Testing of a Group Clinical Visit Adherence Intervention for HIV+ Women of Color
The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads (VL). Participants will be randomized to Sisters-GPS (intervention involving weekly group clinical visits for seven weeks plus social media website) or appointment with an adherence counselor (a minimum of 3 visits) (control condition). Data sources will include interviews, medical and pharmacy records, and blood samples. The primary outcome will be ARV adherence at the completion of the intervention assessed via pill count. The secondary outcome will be HIV VL suppression.
Read the detailed description
African American and Latina women comprise about 80% of the approximately 300,000 HIV-positive women in the United States. HIV/AIDS is one of the leading causes of death among African American and Latina women age 20 to 55 years. HIV-positive women of color are disproportionately impacted by poverty and other factors such as substance abuse and mental illness which increase vulnerability to HIV and risk of poor health outcomes (e.g., progression to AIDS and death).
The stages of HIV treatment cascade include linkage to and retention in HIV care, antiretroviral (ARV) utilization, and viral suppression. While all of these stages are important, what has ultimately lengthened life expectancy among HIV-positive persons has been achieving long-term viral suppression by optimizing ARV adherence. Suboptimal ARV adherence is associated with increased risk of progression to AIDS, mortality, and the development of ARV resistance. Recent studies indicate that significant racial and ethnic disparities in ARV adherence persist, with African Americans and Latinos having lower levels of adherence than whites. This disparity is also reflected among HIV+ women, with women of color, and in particular African American women, having significantly lower rates of ARV adherence than white women.
Peer-based health interventions have been shown to affect behavior and improve patient outcomes. For HIV-positive persons, receiving care within a group of peers is associated with decreased levels of shame, HIV-related stigma, and risk behaviors, and increased levels of perceived social support. A group-based approach to care involving peers may be especially important for HIV-positive women of color as HIV-positive women of color may lack positive social support. Consequently, the peer-group dynamic may help not only to normalize living with HIV and provide social support but also to motivate healthy behaviors such as ARV adherence.
Group clinical visits, in which the same group of patients who share a common medical condition receives care simultaneously from a health care provider over time, is a model of care that seeks to take advantage of the peer-group dynamic. This model often includes a clinical assessment, education, and self-management skills development, all in the group setting. It has been utilized in the care of patients with chronic conditions such as diabetes mellitus and Hepatitis C infection and improves health outcomes. Therefore, guided by an enhanced version of the Social Learning Theory, which posits that people learn not only from their own experiences but from the experiences and actions of others, the investigators will tailor the group clinical visit model to a model of group HIV treatment focused on optimizing ARV adherence.
Use of social media, whereby people interact by creating, sharing, and exchanging content using internet-based technologies, transcends race/ethnicity and socioeconomic status. Within the arena of health care, its use is becoming increasingly popular. For example, social media is used by persons who may have a common medical condition, such as HIV, to communicate about coping with the disease or taking medications. Among HIV-positive persons, social media may be used to enhance communication and social support; hence, the investigators have incorporated social media as a component of Sisters-GPS.
To begin to address disparities in ARV adherence and the limitations of current interventions, the investigators will test Sisters-GPS, an intervention for HIV-positive women of color with suboptimal ARV adherence that the investigators have developed. Sisters-GPS is an intervention adapted from the group clinical visit and which incorporated social media. If proven effective, this intervention has the potential to be a model of health care delivery for HIV care and treatment, more generally, and can be disseminated to diverse clinical settings.
- Conditions
- Adherence, Patient, HIV/AIDS, Group Meetings
- Being tested
- Sisters-GPS: Group Clinical Visits, Control: One-on-one Adherence Counseling
- Keywords
- HIV treatment, Adherence Group Treatment
- Medical subject headings
- Patient Compliance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sisters-GPS: Group Clinical VisitsBehavioural
Sisters-GPS will be involve group clinical visits where by the same group participants with meet with a clinician and behaviorist to receive education, self-management skills development, and clinical assessment over the seven weekly group visits. The content will focus specifically on HIV medications and medication adherence. Additionally, the intervention will involve a private social media website where participants will be able to engage with one another between group clinical visits. Participants will receive food and a roundtrip Metrocard at each group clinical visit.
Control: One-on-one Adherence CounselingBehavioural
For participants in the control arm, the counselor will provide standard-of-care adherence counseling, which includes education about ARVs and the importance of adherence, and addressing non-adherence including assessment of psychosocial barriers to adherence. For visits to the adherence counselor, participants will receive round-trip MetroCards as per clinic policy. Control arm participants will be expected to attend a minimum of three visits with the adherence counselor.
| Study group | Role | What they receive |
|---|---|---|
| Sisters-GPS: Group Clinical Visits | Experimental | Those randomized to the Sisters-GPS arm will be expected to attend a total of seven group clinical visits, once a week for ~1.5 hours. Groups visits will include education, self-management skills development, and a clinical assessment by a medical provider with a focus on HIV treatment and adherence. Additionally, Sisters-GPS participants will be encouraged to participate in a private social media site specifically designed for the study, where participants will be able communicate with one another and with research staff. Group size will be 8-10 participants. Receives: Behavioral: Sisters-GPS: Group Clinical Visits |
| Control: One-on-one Adherence Counseling | Active comparator | Those randomized to the control condition will receive an appointment with a HIV treatment adherence counselor and will be expected to attend a minimum of three adherence counseling visits. . Receives: Behavioral: Control: One-on-one Adherence Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral Therapy (ARV) adherence
Pill count, self-report
Measured: 8 weeks
Secondary outcomes (6)
Change in HIV viral load
Change in HIV viral load from baseline to 8 weeks modeled as continuous variable
Measured: 8 weeks
HIV Viral Load (VL) suppression
HIV VL used as a dichotomous measure (VL<40 copies/mL, yes/no)
Measured: 8 weeks
Antiretroviral Therapy (ARV) adherence
Pill count, self-report
Measured: 4 weeks
Antiretroviral Therapy (ARV) adherence
Pill count, self-report
Measured: 20 weeks
HIV Viral Load (VL) suppression
HIV VL used as a dichotomous measure (VL<40 copies/mL, yes/no)
Measured: 20 weeks
Change in HIV viral load
Change in HIV viral load from baseline to 8 weeks modeled as continuous variable
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start17 May 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Why it stopped: The funding for the study was relinquished and so study terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Model description
- The investigators pilot test efficacy of Sisters-GPS intervention in improving ARV adherence by randomizing 60 HIV+ women of color with suboptimal ARV adherence and detectable HIV viral loads (VL) to Sisters-GPS, group clinical visits, or to an appointment with an adherence counselor. The investigators will collect data from interviews, pill counts, medical and pharmacy records, and blood samples. The study's primary outcome will be ARV adherence assessed by pill count at 8 weeks; secondary outcome will be change in HIV VL from baseline to 8 weeks.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Albert Einstein College of Medicine, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Oni Blackstock, Montefiore Medical Center
- Investigators
- Oni Blackstock, MD, MHS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109743
- Sponsor's protocol ID
- 2016-7257
- Other IDs
- K23MH102129
- Status last verified
- Jun 2018
- First submitted
- 6 Apr 2017
- Last updated
- 8 Jun 2018
- 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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Group Clinical Visit Adherence Intervention for HIV+ Women of Color
- ClinicalTrials.gov ID
- NCT03109743
- Acronym / sponsor ID
- 2016-7257
- Conditions
- Adherence, Patient, HIV/AIDS, Group Meetings
- Keywords
- HIV treatment, Adherence Group Treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding for the study was relinquished and so study terminated early.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Albert Einstein College of Medicine, National Institute of Mental Health (NIMH)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 12 Apr 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.
The investigators will conduct a pilot randomized controlled trial (RCT) of Sisters-GPS with HIV-positive women of color with suboptimal ARV adherence and detectable HIV viral loads (VL). Participants will be randomized to Sisters-GPS (intervention involving weekly group clinical visits for seven weeks plus social media website) or appointment with an adherence counselor (a minimum of 3 visits) (control condition). Data sources will include interviews, medical and pharmacy records, and blood samples. The primary outcome will be ARV adherence at the completion of the intervention assessed via pill count. The secondary outcome will be HIV VL suppression.
Detailed description
African American and Latina women comprise about 80% of the approximately 300,000 HIV-positive women in the United States. HIV/AIDS is one of the leading causes of death among African American and Latina women age 20 to 55 years. HIV-positive women of color are disproportionately impacted by poverty and other factors such as substance abuse and mental illness which increase vulnerability to HIV and risk of poor health outcomes (e.g., progression to AIDS and death).
The stages of HIV treatment cascade include linkage to and retention in HIV care, antiretroviral (ARV) utilization, and viral suppression. While all of these stages are important, what has ultimately lengthened life expectancy among HIV-positive persons has been achieving long-term viral suppression by optimizing ARV adherence. Suboptimal ARV adherence is associated with increased risk of progression to AIDS, mortality, and the development of ARV resistance. Recent studies indicate that significant racial and ethnic disparities in ARV adherence persist, with African Americans and Latinos having lower levels of adherence than whites. This disparity is also reflected among HIV+ women, with women of color, and in particular African American women, having significantly lower rates of ARV adherence than white women.
Peer-based health interventions have been shown to affect behavior and improve patient outcomes. For HIV-positive persons, receiving care within a group of peers is associated with decreased levels of shame, HIV-related stigma, and risk behaviors, and increased levels of perceived social support. A group-based approach to care involving peers may be especially important for HIV-positive women of color as HIV-positive women of color may lack positive social support. Consequently, the peer-group dynamic may help not only to normalize living with HIV and provide social support but also to motivate healthy behaviors such as ARV adherence.
Group clinical visits, in which the same group of patients who share a common medical condition receives care simultaneously from a health care provider over time, is a model of care that seeks to take advantage of the peer-group dynamic. This model often includes a clinical assessment, education, and self-management skills development, all in the group setting. It has been utilized in the care of patients with chronic conditions such as diabetes mellitus and Hepatitis C infection and improves health outcomes. Therefore, guided by an enhanced version of the Social Learning Theory, which posits that people learn not only from their own experiences but from the experiences and actions of others, the investigators will tailor the group clinical visit model to a model of group HIV treatment focused on optimizing ARV adherence.
Use of social media, whereby people interact by creating, sharing, and exchanging content using internet-based technologies, transcends race/ethnicity and socioeconomic status. Within the arena of health care, its use is becoming increasingly popular. For example, social media is used by persons who may have a common medical condition, such as HIV, to communicate about coping with the disease or taking medications. Among HIV-positive persons, social media may be used to enhance communication and social support; hence, the investigators have incorporated social media as a component of Sisters-GPS.
To begin to address disparities in ARV adherence and the limitations of current interventions, the investigators will test Sisters-GPS, an intervention for HIV-positive women of color with suboptimal ARV adherence that the investigators have developed. Sisters-GPS is an intervention adapted from the group clinical visit and which incorporated social media. If proven effective, this intervention has the potential to be a model of health care delivery for HIV care and treatment, more generally, and can be disseminated to diverse clinical settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators pilot test efficacy of Sisters-GPS intervention in improving ARV adherence by randomizing 60 HIV+ women of color with suboptimal ARV adherence and detectable HIV viral loads (VL) to Sisters-GPS, group clinical visits, or to an appointment with an adherence counselor. The investigators will collect data from interviews, pill counts, medical and pharmacy records, and blood samples. The study's primary outcome will be ARV adherence assessed by pill count at 8 weeks; secondary outcome will be change in HIV VL from baseline to 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Sisters-GPS: Group Clinical Visits | Experimental | Behavioral: Sisters-GPS: Group Clinical VisitsThose randomized to the Sisters-GPS arm will be expected to attend a total of seven group clinical visits, once a week for ~1.5 hours. Groups visits will include education, self-management skills development, and a clinical assessment by a medical provider with a focus on HIV treatment and adherence. Additionally, Sisters-GPS participants will be encouraged to participate in a private social media site specifically designed for the study, where participants will be able communicate with one another and with research staff. Group size will be 8-10 participants. |
| Control: One-on-one Adherence Counseling | Active comparator | Behavioral: Control: One-on-one Adherence CounselingThose randomized to the control condition will receive an appointment with a HIV treatment adherence counselor and will be expected to attend a minimum of three adherence counseling visits. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV-positive
- Cis gender women (assigned female sex at birth and current identifies as female)
- ≥ 18 years old
- English proficiency
- At least one visit to community health center where received HIV primary care within the last 12 months
Key exclusion criteria (2 listed)
- Untreated severe mental illness including major depressive disorder, bipolar disorder, schizophrenia, psychosis, or current suicidal ideation.
- Acute intoxication
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 |
|---|---|---|
| Sisters-GPS: Group Clinical VisitsSisters-GPS will be involve group clinical visits where by the same group participants with meet with a clinician and behaviorist to receive education, self-management skills development, and clinical assessment over the seven weekly group visits. The content will focus specifically on HIV medications and medication adherence. Additionally, the intervention will involve a private social media website where participants will be able to engage with one another between group clinical visits. Participants will receive food and a roundtrip Metrocard at each group clinical visit. | Behavioural | Sisters-GPS: Group Clinical Visits |
| Control: One-on-one Adherence CounselingFor participants in the control arm, the counselor will provide standard-of-care adherence counseling, which includes education about ARVs and the importance of adherence, and addressing non-adherence including assessment of psychosocial barriers to adherence. For visits to the adherence counselor, participants will receive round-trip MetroCards as per clinic policy. Control arm participants will be expected to attend a minimum of three visits with the adherence counselor. | Behavioural | Control: One-on-one Adherence Counseling |
Primary outcome
Antiretroviral Therapy (ARV) adherence
Time frame: 8 weeks
Pill count, self-report
6 secondary outcomes
Change in HIV viral load
Time frame: 8 weeks
HIV Viral Load (VL) suppression
Time frame: 8 weeks
Antiretroviral Therapy (ARV) adherence
Time frame: 4 weeks
Antiretroviral Therapy (ARV) adherence
Time frame: 20 weeks
HIV Viral Load (VL) suppression
Time frame: 20 weeks
Change in HIV viral load
Time frame: 20 weeks
Results and safety
The study was stopped early (reason given: The funding for the study was relinquished and so study terminated early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- 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.
Oni Blackstock, MD, MHS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sisters-GPS: Group Clinical Visits in people with Adherence, Patient and HIV/AIDS, run by Montefiore Medical Center 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 10 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Jun 2018. 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 was stopped early (reason given: The funding for the study was relinquished and so study terminated early.). Results are not available in the source record.
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?
Antiretroviral Therapy (ARV) adherence (time frame: 8 weeks). 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 8 Jun 2018.