HIVRapITNCT01710397
Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
A study testing Rapid ART initiation in people with HIV, run by Boston University at 2 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Rapid ART initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 531 participants
- Where
- 2 sitesSouth Africa
- Study dates
- May 2013to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Thuthukani Primary Health Clinic
Johannesburg, Gauteng, 2092
Themba Lethu Clinic, Helen Joseph Hospital
Johannesburg, Gauteng
About this study
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.
- Conditions
- HIV
- Being tested
- Rapid ART initiation
- Keywords
- Antiretroviral therapy, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid ART initiationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard group, non-pregnant adults | No intervention | Comparison group (prospective enrollment) |
| Standard group, pregnant women | No intervention | Comparison group (retrospective record review) |
| Rapid group, non-pregnant adults | Experimental | Rapid ART initiation Receives: Other: Rapid ART initiation |
| Rapid group, pregnant women | Experimental | Rapid ART initiation Receives: Other: Rapid ART initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion non-pregnant subjects virally suppressed at routine six-month viral load
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.
Measured: 10 months after study enrollment
Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery
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.
Measured: Up to 9 months after study enrollment
Secondary outcomes (7)
Average cost per non-pregnant patient who is alive, in care, and virally suppressed within 10 months of study enrollment
Measured: 10 months after study enrollment
Average cost per pregnant patient who initiates ART within 4 weeks
Measured: 3 months after study enrollment
Proportion virally suppressed at six-month intervals and final date of data censoring
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
Measured: 24 months after enrollment
Average time to ART initiation
Measured: 24 months after enrollment
Average gestational age at ART initiation and average duration on ART prior to delivery
Measured: 3 months after study enrollment
Patient-level predictors of treatment uptake, retention in care, and viral suppression
Measured: 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
Measured: 10 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa
- Responsible party
- Principal investigator, Sydney Rosen, Boston University
- Investigators
- Sydney Rosen, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710397
- Sponsor's protocol ID
- H-31880
- Other IDs
- 1U01AI100015-01
- Acronym
- RapIT
- Status last verified
- Jan 2019
- First submitted
- 7 Sep 2012
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made publicly available in the Dryad repository (http://www. datadryad.org/) after the protocol has been closed (anticipated closure December 2018).
Publications
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.
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.
PubMed 27163694Rosen 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.
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.
PubMed 28463879Maskew 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.
PubMed 30161147
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
- ClinicalTrials.gov ID
- NCT01710397
- Acronym / sponsor ID
- RapIT / H-31880
- Conditions
- HIV
- Keywords
- Antiretroviral therapy, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa
- Study start
- May 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard group, non-pregnant adults | No intervention | –Comparison group (prospective enrollment) |
| Standard group, pregnant women | No intervention | –Comparison group (retrospective record review) |
| Rapid group, non-pregnant adults | Experimental | Other: Rapid ART initiationRapid ART initiation |
| Rapid group, pregnant women | Experimental | Other: Rapid ART initiationRapid ART initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid ART initiationSubjects 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. | Other | Rapid group, non-pregnant adults, Rapid group, pregnant women |
Primary outcome
Proportion non-pregnant subjects virally suppressed at routine six-month viral load
Time frame: 10 months after study enrollment
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
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.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Results publicationRosen 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.
- Results publication: PubMed 27163694Rosen 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.
- Results publicationRosen 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.
- Results publication: PubMed 28463879Long 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.
- Results publication: PubMed 30161147Maskew 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.
- Website of implementing organization in South AfricaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made publicly available in the Dryad repository (http://www. datadryad.org/) after the protocol has been closed (anticipated closure December 2018).
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sydney Rosen principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid ART initiation in people with HIV, run by Boston University at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion non-pregnant subjects virally suppressed at routine six-month viral load (time frame: 10 months after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710397, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.