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

Hiv Clinical Trial

Official title:

Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567693
• Other study ID #: 2020-11551
• Secondary ID: K23MH114752
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: July 18, 2022

Study information

• Verified date: October 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 18, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aids
• Hiv

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Rwanda Military Hospital	Kigali

Sponsors (4)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine, National Institute of Mental Health (NIMH), Rwanda Military Hospital

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Enacted and Internalized Stigmas	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), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).	Measured at 6 months after enrollment in ART care
Other	Participant Health-related Costs	Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center.	12-months
Other	ART Adherence	Repeated measures analysis of patient self-reported ART adherence	Measured at 12-months after enrollment in ART care
Other	ART Adherence	Repeated measures analysis of patient self-reported ART adherence	Measured at 6 months after enrollment in ART care
Other	Perceived Quality of Life	Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). 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. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.	Measured at 6 months after enrollment in ART care
Other	Perceived Quality of Life	Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). 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. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.	Measured at 12 months after enrollment in ART care
Other	Satisfaction With Care	The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.	Measured at 6 months after enrollment in ART care
Other	Anticipated Stigma	As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score.	Measured at 6 months after enrollment in ART care
Other	Anticipated Stigma	As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely [1] to Very Likely [5]), with higher scores indicating greater stigma. Items are averaged to create a composite score.	Measured at 12 months after enrollment in ART care
Other	Enacted and Internalized Stigmas	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), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).	Measured at 12 months after enrollment in ART care
Primary	Viral Suppression	Percentage of participants with suppressed viral load (less than 200 copies/ml)	Measured at 12 months after enrollment into ART care
Secondary	Appointment Adherence	Proportion of participants that attended all pharmacy and clinical appointments	Measured at 12 months after enrollment into ART care
Secondary	Participant Acceptability of Reduced Time to Spaced-out Appointments	The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.	Measured at 12 months after enrollment into ART care
Secondary	Provider Acceptability of Reduced Time to Spaced-out Appointments	Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant.	Measured at 12 months after enrollment into ART care