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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Hiv, Aids

Intervention / Treatment
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* Other: Early spaced-out appointments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥15 years; newly-diagnosed with HIV (within 6 months); enrolled in care at study health facility; initiated ART. Exclusion Criteria: planning on moving away from health center/Kigali in the next 12 months; unable to provide informed consent; enrolled in care while pregnant; co-infected with tuberculosis; concurrent known mental health or substance use disorder.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early 1<br>Advance to spaced-out appointments at month 6 after a single viral load is measured. | Other: Early spaced-out appointments<br>* 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.<br>|
| Experimental: Early 2<br>Advance to spaced-out appointments at month 6 after two viral loads are measured. | Other: Early spaced-out appointments<br>* 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.<br>|
| No Intervention: Usual Care<br>Do not advance to spaced-out appointments during study period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | Percentage of participants with suppressed viral load (less than 200 copies/ml) | Measured at 12 months after enrollment into ART care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appointment Adherence | Proportion of participants that attended all pharmacy and clinical appointments | Measured at 12 months after enrollment into ART care | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rwanda, Treat All, Antiretroviral therapy