Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV

Sponsor
Montefiore Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04567693
Collaborator
National Institute of Mental Health (NIMH) (NIH), Albert Einstein College of Medicine (Other), Rwanda Military Hospital (Other)
93
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20.8
4.5

Study Details

Study Description

Brief Summary

The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).

Condition or Disease Intervention/Treatment Phase
  • Other: Early spaced-out appointments
N/A

Detailed Description

Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as "unstable", requiring monthly visits to the health facility. Before they can advance to being "stable" patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the "unstable" category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the "stable" category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) ("Early 1"); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) ("Early 2"); and 30 will be randomized to continue in usual care with monthly visits ("Usual care"). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the "stable" category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study
Actual Study Start Date :
Oct 22, 2020
Actual Primary Completion Date :
Apr 26, 2022
Actual Study Completion Date :
Jul 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early 1

Advance to spaced-out appointments at month 6 after a single viral load is measured.

Other: Early spaced-out appointments
Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.

Experimental: Early 2

Advance to spaced-out appointments at month 6 after two viral loads are measured.

Other: Early spaced-out appointments
Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.

No Intervention: Usual Care

Do not advance to spaced-out appointments during study period

Outcome Measures

Primary Outcome Measures

  1. Viral suppression [Measured at 12 months after enrollment into ART care]

    Proportion of participants with suppressed viral load (less than 200 copies/ml)

Secondary Outcome Measures

  1. Appointment adherence [Measured at 12 months after enrollment into ART care]

    Proportion of participants that attended all pharmacy and clinical appointments

  2. Participant acceptability of reduced time to spaced-out appointments [Measured at 12 months after enrollment into ART care]

    Acceptability of reduced time to spaced-out appointments, as measured by interview responses

  3. Provider acceptability of reduced time to spaced-out appointments [Measured at 12 months after enrollment into ART care]

    Acceptability of reduced time to spaced-out appointments, as measured by interview responses

Other Outcome Measures

  1. ART adherence [Measured at 1-, 6- and 12-months after enrollment in ART care]

    Repeated measures analysis of patient self-reported ART adherence

  2. Perceived quality of life assessed by the EQ-5D-5L [Measured at 1-, 6- and 12-months after enrollment in ART care]

    Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. Each domain is scored from 1 (no problems) to 5 (extreme problems); the overall health state is described by a 5-digit number defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).

  3. Satisfaction with care assessed by scales developed by Lannes, et al. and Parcescepe, et al. [Measured at 1-, 6- and 12-months after enrollment in ART care]

    Repeated measures analysis of participant satisfaction with health care received as measured by scales developed by Lannes, et al. and Parcescepe, et al. The Lannes scale is a 5-level scale (very satisfied, satisfied, no opinion, not satisfied, very unsatisfied) that asks participants to describe satisfaction with several elements of receiving health care. The Parcescepe, et al scale is a 2-level scale (agree, disagree) that asks participants to agree or disagree with various aspects of care received at the health center.

  4. Enacted stigma assessed by the HASI-P scale [Measured at 1-, 6- and 12-months after enrollment in ART care]

    Repeated measures analysis of enacted stigma in community and health care settings as measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time). The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor. Higher scores are interpreted as reflecting greater levels of received or associated stigma.

  5. Internalized, anticipated and enacted stigma assessed by the HIV stigma scale [Measured at 1-, 6- and 12-months after enrollment in ART care]

    Repeated measures analysis of internalized, anticipated and enacted stigma as measured by an adapted version of the HIV stigma scale. Items are rated on 5-point Likert-type scales (Internalized: ranging from Strongly Disagree [1] to Strongly Agree [5]; Anticipated: ranging from Very Unlikely [1] to Very Likely [5]; Enacted: ranging from Never [1] to Very Often [5]) with higher scores indicating greater stigma. Items are averaged to create composite scores, subdivided by type of stigma (internalized, anticipated or enacted).

  6. Participant health-related costs [Measured at 1-, 6- and 12-months after enrollment in ART care]

    Repeated measures analysis of participant direct and indirect costs

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. ≥15 years;

  2. newly-diagnosed with HIV (within 6 months);

  3. enrolled in care at study health facility;

  4. initiated ART.

Exclusion Criteria:
  1. planning on moving away from health center/Kigali in the next 12 months;

  2. unable to provide informed consent;

  3. enrolled in care while pregnant;

  4. co-infected with tuberculosis;

  5. concurrent known mental health or substance use disorder.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rwanda Military Hospital Kigali Rwanda

Sponsors and Collaborators

  • Montefiore Medical Center
  • National Institute of Mental Health (NIMH)
  • Albert Einstein College of Medicine
  • Rwanda Military Hospital

Investigators

  • Principal Investigator: Jonathan Ross, Montefiore Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT04567693
Other Study ID Numbers:
  • 2020-11551
  • K23MH114752
First Posted:
Sep 28, 2020
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Montefiore Medical Center

Study Results

No Results Posted as of Aug 23, 2022