Overview

This trial is active, not recruiting.

Condition hiv
Treatment rapid art initiation
Sponsor Boston University
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date May 2013
End date July 2015
Trial size 600 participants
Trial identifier NCT01710397, 1U01AI100015-01, H-31880

Summary

One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to care of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require approximately four clinic visits over a period of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation under South African guidelines (lab tests, physical exam, education) to take place on the day the patient presents for an HIV test.

This study is a randomized strategy evaluation of the feasibility, effectiveness, and cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who come to a South African clinic for an HIV test, consent to study participation, and are eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those who are assigned to rapid ART initiation will have the possibility of receiving their first dose of ARVs as early as the same day, while those who are assigned to standard care will follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive pregnant women, which has recently become the standard of care in South Africa, will also be assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a retrospective comparison group. The primary study outcome for non-pregnant adults will be remaining alive, in care and virally suppressed 10 months after having a positive HIV test at the study site or making a first HIV-related visit. The primary study outcome for pregnant women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation strategy will be assessed as the cost per patient achieving the primary outcome for each population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Comparison group (prospective enrollment)
(No Intervention)
Comparison group (retrospective record review)
(Experimental)
Rapid ART initiation
rapid art initiation
Subjects offered the intervention who are eligible for antiretroviral therapy under South African guidelines will be offered the opportunity to initiate ART immediately, if possible on the same day as testing positive for HIV. Rapid testing technologies and an accelerated schedule will be used to allow all steps required prior to initiating ART to take place in approximately a half-day period.
(Experimental)
Rapid ART initiation
rapid art initiation
Subjects offered the intervention who are eligible for antiretroviral therapy under South African guidelines will be offered the opportunity to initiate ART immediately, if possible on the same day as testing positive for HIV. Rapid testing technologies and an accelerated schedule will be used to allow all steps required prior to initiating ART to take place in approximately a half-day period.

Primary Outcomes

Measure
Proportion non-pregnant subjects virally suppressed at routine six-month viral load
time frame: 10 months after study enrollment
Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery
time frame: Up to 9 months after study enrollment

Secondary Outcomes

Measure
Average cost per non-pregnant patient who is alive, in care, and virally suppressed within 10 months of study enrollment
time frame: 10 months after study enrollment
Average cost per pregnant patient who initiates ART within 4 weeks
time frame: 3 months after study enrollment
Proportion virally suppressed at six-month intervals and final date of data censoring
time frame: 24 months after enrollment
Average time to ART initiation
time frame: 24 months after enrollment
Average gestational age at ART initiation and average duration on ART prior to delivery
time frame: 3 months after study enrollment
Patient-level predictors of treatment uptake, retention in care, and viral suppression
time frame: 10 months after enrollment
Prevalence of TB symptoms, confirmed TB, time to initiation of TB treatment, and time to initiation of ART among patients with TB
time frame: 10 months after enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients (>18 years) - Tested HIV-positive at study site's outpatient testing service or antenatal clinic on day of study enrollment or previously tested HIV-positive but making first visit to study site for HIV-related care or antenatal care for the current pregnancy - Eligible for antiretroviral therapy under prevailing South African guidelines Exclusion Criteria: - Currently or previously on ART (three-drug combination; previous PMTCT regimen exposure for an earlier pregnancy is not an exclusion criterion) - Stated intention to seek further HIV or antenatal care at another site, not at the study site - Not physically or emotionally able to participate in the study, in the opinion of the investigators - Not willing or able to provide written informed consent to participate in the study - Previously screened for the same study

Additional Information

Official title Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
Principal investigator Sydney Rosen
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boston University.