Clinical trial NCT01710397: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
Official title: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Antiretroviral therapy
South Africa
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Witwatersrand, South Africa
First posted: 2012-10-19
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility 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

Primary outcomes:
measure: Proportion non-pregnant subjects virally suppressed at routine six-month viral load
timeFrame: 10 months after study enrollment
measure: Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery
timeFrame: 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
timeFrame: 10 months after study enrollment
measure: Average cost per pregnant patient who initiates ART within 4 weeks
timeFrame: 3 months after study enrollment
measure: Proportion virally suppressed at six-month intervals and final date of data censoring
timeFrame: 24 months after enrollment
measure: Average time to ART initiation
timeFrame: 24 months after enrollment
measure: Average gestational age at ART initiation and average duration on ART prior to delivery
timeFrame: 3 months after study enrollment
measure: Patient-level predictors of treatment uptake, retention in care, and viral suppression
timeFrame: 10 months after enrollment
measure: Prevalence of TB symptoms, confirmed TB, time to initiation of TB treatment, and time to initiation of ART among patients with TB
timeFrame: 10 months after enrollment
Other outcomes:
measure: Acceptance of rapid initiation strategy
timeFrame: 10 months after enrollment
measure: Time from HIV test to treatment
timeFrame: 10 months after enrollment
measure: Cost to patients
timeFrame: 10 months after enrollment
Locations:
city: Johannesburg
country: South Africa
facility: Thuthukani Primary Health Clinic
state: Gauteng
city: Johannesburg
country: South Africa
facility: Themba Lethu Clinic, Helen Joseph Hospital
state: Gauteng
Study officials:
affiliation: Boston University
name: Sydney Rosen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen S, Maskew M, Fox MP, Nyoni C, Mongwenyana C, Malete G, Sanne I, Rohr JK, Long L. Rapid ART initiation reduces loss between HIV testing and treatment: the RapIT trial. Abstract 1091, 21st Conference on Retroviruses and Opportunistic Infections (CROI 2015), Seattle, February 23-26, 2015.
citation: Rosen S, Maskew M, Fox MP, Nyoni C, Mongwenyana C, Malete G, Sanne I, Bokaba D, Sauls C, Rohr J, Long L. Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial. PLoS Med. 2016 May 10;13(5):e1002015. doi: 10.1371/journal.pmed.1002015. eCollection 2016 May.
citation: Rosen S, Maskew M, Fox MP, Nyoni C, Mongwenyana C, Malete G, Sanne I, Bokaba D, Sauls C, Rohr R, Long L. Initiating antiretroviral therapy for HIV at a patient's first clinic visit: the RapIT randomized controlled trial. Conference on Retroviruses and Opportunistic Infections (CROI) 2016, Boston, Feb 22-25 2016.
citation: Long LC, Maskew M, Brennan AT, Mongwenyana C, Nyoni C, Malete G, Sanne I, Fox MP, Rosen S. Initiating antiretroviral therapy for HIV at a patient's first clinic visit: a cost-effectiveness analysis of the rapid initiation of treatment randomized controlled trial. AIDS. 2017 Jul 17;31(11):1611-1619. doi: 10.1097/QAD.0000000000001528.
citation: Maskew M, Jamieson L, Mohomi G, Long L, Mongwenyana C, Nyoni C, Mokaba D, Fox MP, Sanne I, Rosen S. Implementation of Option B and a fixed-dose combination antiretroviral regimen for prevention of mother-to-child transmission of HIV in South Africa: A model of uptake and adherence to care. PLoS One. 2018 Aug 30;13(8):e0201955. doi: 10.1371/journal.pone.0201955. eCollection 2018.