Group Clinical Visit Adherence Intervention for HIV+ Women of Color

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.

Conditions

• Adherence, Patient
• HIV/AIDS
• Group Meetings

Interventions

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.

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Albert Einstein College of Medicine

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• Oni Blackstock, MD, MHS · Montefiore Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-17

Primary Completion

2017-12-07

Completion

2017-12-07

Countries

• United States

Study Locations