Clinical trial NCT03109743: Group Clinical Visit Adherence Intervention for HIV+ Women of Color
Official title: Development and Testing of a Group Clinical Visit Adherence Intervention for HIV+ Women of Color
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adherence, Patient
HIV/AIDS
Group Meetings
Keywords: HIV treatment
Adherence Group Treatment
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Albert Einstein College of Medicine
name: National Institute of Mental Health (NIMH)
First posted: 2017-04-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antiretroviral Therapy (ARV) adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in HIV viral load
timeFrame: 8 weeks
measure: HIV Viral Load (VL) suppression
timeFrame: 8 weeks
measure: Antiretroviral Therapy (ARV) adherence
timeFrame: 4 weeks
measure: Antiretroviral Therapy (ARV) adherence
timeFrame: 20 weeks
measure: HIV Viral Load (VL) suppression
timeFrame: 20 weeks
measure: Change in HIV viral load
timeFrame: 20 weeks
Other outcomes:
measure: ARV beliefs and attitudes
timeFrame: at baseline, 4 weeks, 8 weeks, 20 weeks
measure: ARV Knowledge
timeFrame: at baseline, 4 weeks, 8 weeks, 20 weeks
measure: Medication side effects
timeFrame: at baseline, 4 weeks, 8 weeks, 20 weeks
measure: Perceived self-efficacy
timeFrame: at baseline, 4 weeks, 8 weeks, 20 weeks
measure: Perceived HIV-related stigma
timeFrame: at baseline, 4 weeks, 8 weeks, 20 weeks
measure: Perceived social support
timeFrame: at baseline, 4 weeks, 8 weeks, 20 weeks
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Oni Blackstock, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: