Group Clinical Visit Adherence Intervention for HIV+ Women of Color

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.

Study Overview

• Status: Terminated
• Conditions: HIV/AIDS; Adherence, Patient; Group Meetings
• Intervention / Treatment: Behavioral: Sisters-GPS: Group Clinical Visits; Behavioral: Control: One-on-one Adherence Counseling

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria:

1. HIV-positive
2. Cis gender women (assigned female sex at birth and current identifies as female)
3. ≥ 18 years old
4. English proficiency
5. At least one visit to community health center where received HIV primary care within the last 12 months
6. Self-reported ARV adherence <100% in the previous 30 days
7. Most recent HIV viral load in last 12 months detectable
8. Prescribed HIV medications for at least 16 weeks prior to detectable HIV viral load
9. Currently prescribed HIV medications (i.e., current active HIV medication prescription in electronic medical record or pharmacy)
10. Able to attend most/all group visits

Exclusion Criteria:

1. Untreated severe mental illness including major depressive disorder, bipolar disorder, schizophrenia, psychosis, or current suicidal ideation.
2. Acute intoxication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sisters-GPS: Group Clinical Visits; 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.	Behavioral: Sisters-GPS: Group Clinical Visits; 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.
Active Comparator: Control: One-on-one Adherence Counseling; 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. .	Behavioral: Control: One-on-one Adherence Counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral Therapy (ARV) adherence	Pill count, self-report	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIV viral load	Change in HIV viral load from baseline to 8 weeks modeled as continuous variable	8 weeks
HIV Viral Load (VL) suppression	HIV VL used as a dichotomous measure (VL<40 copies/mL, yes/no)	8 weeks
Antiretroviral Therapy (ARV) adherence	Pill count, self-report	4 weeks
Antiretroviral Therapy (ARV) adherence	Pill count, self-report	20 weeks
HIV Viral Load (VL) suppression	HIV VL used as a dichotomous measure (VL<40 copies/mL, yes/no)	20 weeks
Change in HIV viral load	Change in HIV viral load from baseline to 8 weeks modeled as continuous variable	20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARV beliefs and attitudes	Measure using an ARV beliefs and attitudes questionnaire	at baseline, 4 weeks, 8 weeks, 20 weeks
ARV Knowledge	Measure using a HIV Treatment Knowledge Scale	at baseline, 4 weeks, 8 weeks, 20 weeks
Medication side effects	Measure using Treatment Satisfaction Questionnaire for Medication	at baseline, 4 weeks, 8 weeks, 20 weeks
Perceived self-efficacy	Measure using an ARV adherence Self-Efficacy Scale	at baseline, 4 weeks, 8 weeks, 20 weeks
Perceived HIV-related stigma	Measure using the HIV Stigma Scale	at baseline, 4 weeks, 8 weeks, 20 weeks
Perceived social support	Measured using Scale of Perceived Social Support	at baseline, 4 weeks, 8 weeks, 20 weeks

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute of Mental Health (NIMH); Albert Einstein College of Medicine; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Oni Blackstock, MD, MHS, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): December 7, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: HIV treatment; Adherence Group Treatment
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2016-7257; K23MH102129 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No