NCT03109743

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

April 6, 2017

Last Update Submit

June 6, 2018

Conditions

Adherence, PatientHIV/AIDSGroup Meetings

Keywords

HIV treatmentAdherence Group Treatment

Outcome Measures

Primary Outcomes (1)

  • Antiretroviral Therapy (ARV) adherence

    Pill count, self-report

    8 weeks

Secondary Outcomes (6)

  • Change in HIV viral load

    8 weeks

  • HIV Viral Load (VL) suppression

    8 weeks

  • Antiretroviral Therapy (ARV) adherence

    4 weeks

  • Antiretroviral Therapy (ARV) adherence

    20 weeks

  • HIV Viral Load (VL) suppression

    20 weeks

  • +1 more secondary outcomes

Other Outcomes (6)

  • ARV beliefs and attitudes

    at baseline, 4 weeks, 8 weeks, 20 weeks

  • ARV Knowledge

    at baseline, 4 weeks, 8 weeks, 20 weeks

  • Medication side effects

    at baseline, 4 weeks, 8 weeks, 20 weeks

  • +3 more other outcomes

Study Arms (2)

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.

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. .

Behavioral: Control: One-on-one Adherence Counseling

Interventions

Sisters-GPS: Group Clinical VisitsBEHAVIORAL

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.

Sisters-GPS: Group Clinical Visits
Control: One-on-one Adherence CounselingBEHAVIORAL

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.

Control: One-on-one Adherence Counseling

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIndividual assigned female sex at birth and who currently identify as female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Patient ComplianceAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Oni Blackstock, MD, MHS

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 12, 2017

Study Start

May 17, 2017

Primary Completion

December 7, 2017

Study Completion

December 7, 2017

Last Updated

June 8, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)