Clinical trial NCT04567693: Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV
Official title: Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Aids
Keywords: Rwanda
Treat All
Antiretroviral therapy
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Albert Einstein College of Medicine
name: Rwanda Military Hospital
First posted: 2020-09-28
Enrollment: 93
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

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.

Primary outcomes:
measure: Viral Suppression
timeFrame: Measured at 12 months after enrollment into ART care
Secondary outcomes:
measure: Appointment Adherence
timeFrame: Measured at 12 months after enrollment into ART care
measure: Participant Acceptability of Reduced Time to Spaced-out Appointments
timeFrame: Measured at 12 months after enrollment into ART care
measure: Provider Acceptability of Reduced Time to Spaced-out Appointments
timeFrame: Measured at 12 months after enrollment into ART care
Other outcomes:
measure: Enacted and Internalized Stigmas
timeFrame: Measured at 6 months after enrollment in ART care
measure: Participant Health-related Costs
timeFrame: 12-months
measure: ART Adherence
timeFrame: Measured at 12-months after enrollment in ART care
measure: ART Adherence
timeFrame: Measured at 6 months after enrollment in ART care
measure: Perceived Quality of Life
timeFrame: Measured at 6 months after enrollment in ART care
measure: Perceived Quality of Life
timeFrame: Measured at 12 months after enrollment in ART care
measure: Satisfaction With Care
timeFrame: Measured at 6 months after enrollment in ART care
measure: Anticipated Stigma
timeFrame: Measured at 6 months after enrollment in ART care
measure: Anticipated Stigma
timeFrame: Measured at 12 months after enrollment in ART care
measure: Enacted and Internalized Stigmas
timeFrame: Measured at 12 months after enrollment in ART care
Locations:
city: Kigali
country: Rwanda
facility: Rwanda Military Hospital
Study officials:
affiliation: Montefiore Medical Center
name: Jonathan Ross
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross J, Murenzi G, Hill S, Remera E, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Habimana DS, Mugwaneza P, Zhang C, Yotebieng M, Anastos K. Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study. BMJ Open. 2021 Apr 24;11(4):e047443. doi: 10.1136/bmjopen-2020-047443.