Evaluating the impact of reduced facility waiting time on HIV treatment adherence

Last registered on August 26, 2020

Pre-Trial

Trial Information

General Information

Title
Evaluating the impact of reduced facility waiting time on HIV treatment adherence
RCT ID
AEARCTR-0004190
Initial registration date
May 10, 2019
Last updated
August 26, 2020, 4:43 PM EDT

Locations

Region

Primary Investigator

Affiliation
Brown University

Other Primary Investigator(s)

PI Affiliation
London School of Economics
PI Affiliation
Harvard TC Chan School of Public Health
PI Affiliation
The Pontifical Catholic University of Rio de Janeiro

Additional Trial Information

Status
In development
Start date
2020-09-14
End date
2021-10-08
Secondary IDs
Abstract
Patients receiving HIV treatment need to visit health facilities frequently to obtain antiretroviral treatment (ART) refills and clinical care. At the facility, services are provided on a first-come first-serve basis and long waiting time is pervasive. This proposal aims to evaluate an appointment scheduling intervention for HIV patients receiving ART. This study will be randomized at the health facility level. Half of the study health facilities will be randomized to the scheduling intervention treatment group. In these facilities, all patients receiving HIV treatment will be given a scheduled appointment – with a return date and time – for their next visit. We will measure waiting time in all facilities during three rounds of data collection, and administrative data will be used to assess return visit delays up to one year after the start of the intervention.
External Link(s)

Registration Citation

Citation
de Albuquerque, Amanda et al. 2020. "Evaluating the impact of reduced facility waiting time on HIV treatment adherence." AEA RCT Registry. August 26. https://doi.org/10.1257/rct.4190-1.1
Former Citation
de Albuquerque, Amanda et al. 2020. "Evaluating the impact of reduced facility waiting time on HIV treatment adherence." AEA RCT Registry. August 26. https://www.socialscienceregistry.org/trials/4190/history/74753
Experimental Details

Interventions

Intervention(s)
Appointment scheduling (with a date and time window) for HIV clinical care and ART pharmacy pick-up
Intervention Start Date
2020-10-05
Intervention End Date
2021-10-08

Primary Outcomes

Primary Outcomes (end points)
• Average hourly volume of patients waiting (6 months after the start of the intervention)
• Waiting time for HIV clinical services measured at midline (6 months after the start of the intervention) in minutes
• Waiting time for HIV pharmacy services measured at midline in minutes
• Number of ≥ 7-day delays between months 0-6 among patients who initiated ART in the month after the start of the intervention
• Medication possession ratio (MPR) at least 95%, 6-month window [ Time Frame: 0-6 month interval from date of study enrollment] among patients who initiated ART in the month after the start of the intervention
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
• Time spent on remunerative activities on day of visit to HIV clinic
• Time spent on childcare responsibilities on day of visit to HIV clinic
• Health worker friendliness
• Health worked asked how the patient was doing emotionally
• Health worker perceived to be rushed
• Any ≥ 7-day delay in recommended testing
• Retention in care during one year of follow-up
• Burnout index for health care providers measured at midline and endline
• waiting time for HIV clinical services measured at endline
• waiting time for HIV pharmacy services measured at endline
• Number of ≥ 7-day delays between months 6-12 among patients who initiated ART in the month after the start of the intervention
• Medication possession ratio (MPR) at least 95%, 6-month window [ Time Frame: 6-12 month interval from date of study enrollment] among patients who initiated ART in the month after the start of the intervention
• Providers’ reported satisfaction with their work at the facility
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Randomized controlled trial
Experimental Design Details
Randomization Method
Randomization done in office by a computer - Stata
Randomization Unit
Health facility
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
70
Sample size: planned number of observations
• Waiting time data collected from patients seeking HIV treatment: 43,750 (approximately 25 per day from 70 health facilities for a total of 25 days (10 days at baseline, 5 days at midline, and 10 days at endline) • Number of patients whose administrative records we expect to observe: 5,250 (approximately 75 new patients in 70 health facilities) • Number of people we expect to collect time use data from: 3,500 (approximately 50 patients in 70 health facilities at endline) • Number of health workers we plan to survey: 350 (approximately 5 health workers in 70 facilities) • Number of health /facility staff we plan to interview for the management survey: 350 (approximately 5 health workers in 70 facilities)
Sample size (or number of clusters) by treatment arms
35 health facilities control, 35 health facilities treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Harvard TH Chan School of Public Health
IRB Approval Date
2019-04-26
IRB Approval Number
IRB19-0462
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials