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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Boston University
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01710397
First received: September 7, 2012
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
HIV
Other: Rapid ART initiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Proportion non-pregnant subjects virally suppressed at routine six-month viral load [ Time Frame: 10 months after study enrollment ] [ Designated as safety issue: No ]
    The primary outcome for non-pregnant adults is the proportion of subjects in each group alive, in care and virally suppressed at the routine six-month monitoring visit within 10 months of a positive HIV test or initial HIV care visit if previously diagnosed. The analysis period will start at study enrollment and continue through the earlier of the patient's six-month viral load or 10 months after the patient's HIV test.

  • Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery [ Time Frame: Up to 9 months after study enrollment ] [ Designated as safety issue: No ]
    The primary outcome for pregnant women is the proportion of subjects in each group who adhere to ART or the prior prevention of mother-to-child transmission (PMTCT) regimen until delivery. The number of weeks a pregnant woman is on ART before delivery is the most important predictor of perinatal HIV transmission7. The guideline change to immediate ART initiation for pregnant women is likely to lead to earlier initiation for most pregnant women, but the intervention will be effective only if patients adhere to ART through the duration of pregnancy. Adherence will be measured as making monthly medication pickups to allow a continuous supply of ARVs through delivery. The analysis period for the primary outcome will start on the day of study enrollment, which is the date of a positive HIV test or the first antenatal visit of the current pregnancy, for women previously diagnosed, and end at the actual or estimated delivery date.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Average cost per pregnant patient who initiates ART within 4 weeks [ Time Frame: 3 months after study enrollment ] [ Designated as safety issue: No ]
  • Proportion virally suppressed at six-month intervals and final date of data censoring [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]
    Proportion of subjects in each track and group alive, on ART, and virally suppressed at six-month intervals and the final date of data censoring

  • Average time to ART initiation [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]
  • Average gestational age at ART initiation and average duration on ART prior to delivery [ Time Frame: 3 months after study enrollment ] [ Designated as safety issue: No ]
  • Patient-level predictors of treatment uptake, retention in care, and viral suppression [ Time Frame: 10 months after enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Acceptance of rapid initiation strategy [ Time Frame: 10 months after enrollment ] [ Designated as safety issue: No ]
    Acceptance of rapid initiation strategy (% of patients offered rapid initiation who accept)

  • Time from HIV test to treatment [ Time Frame: 10 months after enrollment ] [ Designated as safety issue: No ]
    Average time elapsed (days) between HIV test and dispensing of first dose of ARVs

  • Cost to patients [ Time Frame: 10 months after enrollment ] [ Designated as safety issue: No ]
    Average cost to patients of initiating treatment, including travel and other out-of-pocket costs and time spent in clinic


Estimated Enrollment: 600
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard group, non-pregnant adults
Comparison group (prospective enrollment)
No Intervention: Standard group, pregnant women
Comparison group (retrospective record review)
Experimental: Rapid group, non-pregnant adults
Rapid ART initiation
Other: 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 group, pregnant women
Rapid ART initiation
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710397

Contacts
Contact: Lawrence Long 27-10-001-7930 llong@heroza.org
Contact: Sydney Rosen 6174141273 sbrosen@bu.edu

Locations
South Africa
Thuthukani Primary Health Clinic Recruiting
Johannesburg, Gauteng, South Africa, 2092
Contact: Cynthia Nyoni       cynoni@heroza.org   
Themba Lethu Clinic, Helen Joseph Hospital Not yet recruiting
Johannesburg, Gauteng, South Africa
Contact: Lawrence Long    27-10-001-7930    llong@heroza.org   
Sponsors and Collaborators
Boston University
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Sydney Rosen Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01710397     History of Changes
Other Study ID Numbers: H-31880, 1U01AI100015-01
Study First Received: September 7, 2012
Last Updated: May 30, 2014
Health Authority: South Africa: Human Research Ethics Committee
United States: Institutional Review Board

Keywords provided by Boston University:
Antiretroviral therapy
South Africa

ClinicalTrials.gov processed this record on July 26, 2014