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).
Brief Title
Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hiv
Aids
Eligibility Criteria
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.
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.
Inclusion Criteria
Inclusion Criteria:
1. ≥15 years;
2. newly-diagnosed with HIV (within 6 months);
3. enrolled in care at study health facility;
4. initiated ART.
1. ≥15 years;
2. newly-diagnosed with HIV (within 6 months);
3. enrolled in care at study health facility;
4. initiated ART.
Gender
All
Gender Based
false
Keywords
Rwanda
Treat All
Antiretroviral therapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
15 Years
NCT Id
NCT04567693
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-11551
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study
Primary Outcomes
Outcome Description
Percentage of participants with suppressed viral load (less than 200 copies/ml)
Outcome Measure
Viral Suppression
Outcome Time Frame
Measured at 12 months after enrollment into ART care
Secondary Ids
Secondary Id
K23MH114752
Secondary Outcomes
Outcome Description
Proportion of participants that attended all pharmacy and clinical appointments
Outcome Time Frame
Measured at 12 months after enrollment into ART care
Outcome Measure
Appointment Adherence
Outcome Description
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.
Outcome Time Frame
Measured at 12 months after enrollment into ART care
Outcome Measure
Participant Acceptability of Reduced Time to Spaced-out Appointments
Outcome Description
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.
Outcome Time Frame
Measured at 12 months after enrollment into ART care
Outcome Measure
Provider Acceptability of Reduced Time to Spaced-out Appointments
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Ross
Investigator Email
joross@montefiore.org
Investigator Phone