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

NCT04567693 | Completed Results

• 2 other identifiers: 2020-11551K23MH114752
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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).

Conditions

Hiv; Aids

Keywords

Rwanda; Treat All; Antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

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

  Measured at 12 months after enrollment into ART care

Secondary Outcomes (3)

• Appointment Adherence

  Measured at 12 months after enrollment into ART care

• Participant Acceptability of Reduced Time to Spaced-out Appointments

  Measured at 12 months after enrollment into ART care

• Provider Acceptability of Reduced Time to Spaced-out Appointments

  Measured at 12 months after enrollment into ART care

Other Outcomes (10)

• Enacted and Internalized Stigmas

  Measured at 6 months after enrollment in ART care

• Participant Health-related Costs

  12-months

• ART Adherence

  Measured at 12-months after enrollment in ART care

Study Arms (3)

Early 1

EXPERIMENTAL

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

Other: Early spaced-out appointments

Early 2

EXPERIMENTAL

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

Other: Early spaced-out appointments

Usual Care

NO INTERVENTION

Do not advance to spaced-out appointments during study period

Interventions

Early spaced-out appointments OTHER

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.

Early 1; Early 2

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥15 years;
• newly-diagnosed with HIV (within 6 months);
• enrolled in care at study health facility;
• initiated ART.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Rwanda Military Hospital

Kigali, Rwanda

Location

Related Publications (2)

• Ross J, Anastos K, Hill S, Remera E, Rwibasira GN, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Zhang C, Nash D, Yotebieng M, Murenzi G. Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial. BMC Health Serv Res. 2024 Apr 30;24(1):555. doi: 10.1186/s12913-024-10950-z.

  PMID: 38693537 DERIVED

• 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.

  PMID: 33895720 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Jonathan Ross
• Organization: Montefiore Medical Center

joross@montefiore.org

718-920-7064

Study Officials

• Jonathan Ross

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: October 22, 2020
• Primary Completion: April 26, 2022
• Study Completion: July 18, 2022
• Last Updated: October 25, 2023
• Results First Posted: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)