Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

531 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard group, non-pregnant adults

Comparison group (prospective enrollment)

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard group, pregnant women

Comparison group (retrospective record review)

Group Type NO_INTERVENTION

No interventions assigned to this group

Rapid group, non-pregnant adults

Rapid ART initiation

Group Type EXPERIMENTAL

Rapid ART initiation

Intervention Type OTHER

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.

Rapid group, pregnant women

Rapid ART initiation

Group Type EXPERIMENTAL

Rapid ART initiation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No