HIVNCT02371265
Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
A study testing Adherence and retention package in people with HIV, run by University of Washington at 1 site in Mozambique.
Trial summary
The overall objective of the study is to develop and test a pilot intervention in central Mozambique to implement the new WHO "Option B+" guidelines that seek to increase the proportion of HIV-positive pregnant women in six antenatal care clinics who start antiretroviral therapy (ART) prior to delivery, and are… Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- HIV
- What is being tested?
- Adherence and retention package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 761 participants
- Where
- 1 siteMozambique
- Study dates
- Apr 2012to Aug 2015
- 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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women who test HIV-positive in antenatal care services at target health facilities
Who cannot join
- Pregnant women who arrived at health facilities who already have tested positive
- HIV-positive pregnant women who cannot start ART
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of the study is to develop and test a pilot intervention in central Mozambique to implement the new WHO "Option B+" guidelines that seek to increase the proportion of HIV-positive pregnant women in six antenatal care clinics who start antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.
Read the detailed description
For over 10 years, services to prevent maternal to child HIV-1 transmission (PMTCT) have been scaled-up and integrated into antenatal care (ANC) in the national health system across Mozambique. In 2004, scale-up of anti-retroviral treatment (ART) also began in Mozambique and is now provided at hundreds of health units. In 2010, the World Health Organization developed new treatment guidelines, termed "Option B" that emphasized early initiation of ART in antenatal care for all HIV-positive pregnant women. In 2012, the WHO issued a programmatic update endorsing a third option termed "Option B+" in which HIV positive pregnant women initiate ART during pregnancy regardless of disease progression and continue treatment for life.
The new "Option B+" approach has been adopted by the Ministry of Health (MoH) in Mozambique and is in the early phases of implementation. As in many African settings, numerous health system factors present major challenges to successful adoption of the guidelines. In Mozambique, ANC and HIV testing coverage is high but there is substantial loss-to-follow-up (LTFU) at successive stages in the treatment cascade, limited counseling for women and many barriers to actively tracking those women lost to follow-up. Early Ministry of Health data suggests significant challenges remain for long-term adherence for women started on ART via the new Option B+ framework in Manica and Sofala provinces and throughout Mozambique.
The successful implementation of new WHO guidelines therefore requires major streamlining of links among ANC, PMTCT, and ART services. The overall objective of this study is to develop and test a pilot intervention in central Mozambique to implement the new WHO guidelines, and increase the proportion of HIV-positive pregnant women in target ANC clinics who start ART prior to delivery, without reducing ART adherence in the first 3 months of therapy. The intervention will emphasize a WHO defined "Option B+" approach; HIV-positive mothers will be referred for ART at the time they receive a positive HIV test result in their first ANC visit. The project utilizes an innovative formative research process, which has already been completed, and a stepped wedge implementation science design to evaluate the intervention. The entire study is being conducted in close collaboration with the Center for Operations Research in Beira (known by its Portuguese acronym as CIOB) that is one of three research centers in Mozambique managed by the MOH National Institute of Health (the research arm of the MoH).
- Conditions
- HIV
- Being tested
- Adherence and retention package
- Keywords
- HIV, Mozambique, antenatal care, adherence, retention, pregnancy, HIV-positive mothers retained in ART after 90 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence and retention packageOther
Based on formative research findings, the following core components of the B+ study intervention have been designed and will be stepped in at the study sites to improve early retention in care and adherence:
- Workflow modification: 1) Redefinition of key roles of MCH nurses and task shifting to community health workers (CHW's), and 2) enhanced patient tracking via improved management of registries/charts;
- Adherence and retention package: 1) Creation of "Adherence Committees" at each site to coordinate and systematize patient follow-up, 2) active patient follow-up and home visits by community health workers (CHWs or activistas), 3) use of text messaging to patients by MCH nurses, 4) improved and intensified counseling coordinated with active CHW and text follow-up, and 5) intensified and improved Option B+ training and supportive supervision.
| Study group | Role | What they receive |
|---|---|---|
| Adherence and retention intervention | Experimental | Implementation of adherence and retention package Receives: Other: Adherence and retention package |
| Control | No intervention | Clusters continue without intervention package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention at 30 days
The primary outcome measure for Aim 3 is the proportion of HIV-positive pregnant women tested at the participating ANC sites that successfully initiates appropriate ART and returns for their scheduled 30-day visit for pharmacy refill and evaluation within 45 days.
Measured: 45 days
Adherence at 90 days
The primary outcome measure for Aim 4 is the ART adherence rate through 90 days after ART initiation.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startApr 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Health Alliance International, Ministry of Health, Mozambique
- Responsible party
- Principal investigator, James Pfeiffer, University of Washington
- Investigators
- Rachel Chapman, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371265
- Sponsor's protocol ID
- 42773
- Other IDs
- 1R01HD074557-01
- Status last verified
- May 2023
- First submitted
- 18 Feb 2015
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Cowan JF, Micek M, Cowan JF, Napua M, Hoek R, Gimbel S, Gloyd S, Sherr K, Pfeiffer JT, Chapman RR. Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach. Implement Sci. 2015 Apr 30;10:61. doi: 10.1186/s13012-015-0249-6.
PubMed 25924668
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
- ClinicalTrials.gov ID
- NCT02371265
- Acronym / sponsor ID
- 42773
- Conditions
- HIV
- Keywords
- HIV, Mozambique, antenatal care, adherence, retention, pregnancy, HIV-positive mothers retained in ART after 90 days
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Health Alliance International, Ministry of Health, Mozambique
- Study start
- Apr 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Feb 2015 (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.
The overall objective of the study is to develop and test a pilot intervention in central Mozambique to implement the new WHO "Option B+" guidelines that seek to increase the proportion of HIV-positive pregnant women in six antenatal care clinics who start antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.
Detailed description
For over 10 years, services to prevent maternal to child HIV-1 transmission (PMTCT) have been scaled-up and integrated into antenatal care (ANC) in the national health system across Mozambique. In 2004, scale-up of anti-retroviral treatment (ART) also began in Mozambique and is now provided at hundreds of health units. In 2010, the World Health Organization developed new treatment guidelines, termed "Option B" that emphasized early initiation of ART in antenatal care for all HIV-positive pregnant women. In 2012, the WHO issued a programmatic update endorsing a third option termed "Option B+" in which HIV positive pregnant women initiate ART during pregnancy regardless of disease progression and continue treatment for life.
The new "Option B+" approach has been adopted by the Ministry of Health (MoH) in Mozambique and is in the early phases of implementation. As in many African settings, numerous health system factors present major challenges to successful adoption of the guidelines. In Mozambique, ANC and HIV testing coverage is high but there is substantial loss-to-follow-up (LTFU) at successive stages in the treatment cascade, limited counseling for women and many barriers to actively tracking those women lost to follow-up. Early Ministry of Health data suggests significant challenges remain for long-term adherence for women started on ART via the new Option B+ framework in Manica and Sofala provinces and throughout Mozambique.
The successful implementation of new WHO guidelines therefore requires major streamlining of links among ANC, PMTCT, and ART services. The overall objective of this study is to develop and test a pilot intervention in central Mozambique to implement the new WHO guidelines, and increase the proportion of HIV-positive pregnant women in target ANC clinics who start ART prior to delivery, without reducing ART adherence in the first 3 months of therapy. The intervention will emphasize a WHO defined "Option B+" approach; HIV-positive mothers will be referred for ART at the time they receive a positive HIV test result in their first ANC visit. The project utilizes an innovative formative research process, which has already been completed, and a stepped wedge implementation science design to evaluate the intervention. The entire study is being conducted in close collaboration with the Center for Operations Research in Beira (known by its Portuguese acronym as CIOB) that is one of three research centers in Mozambique managed by the MOH National Institute of Health (the research arm of the MoH).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence and retention intervention | Experimental | Other: Adherence and retention packageImplementation of adherence and retention package |
| Control | No intervention | –Clusters continue without intervention package |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women who test HIV-positive in antenatal care services at target health facilities
Key exclusion criteria (2 listed)
- Pregnant women who arrived at health facilities who already have tested positive
- HIV-positive pregnant women who cannot start ART
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 |
|---|---|---|
| Adherence and retention packageBased on formative research findings, the following core components of the B+ study intervention have been designed and will be stepped in at the study sites to improve early retention in care and adherence: * Workflow modification: 1) Redefinition of key roles of MCH nurses and task shifting to community health workers (CHW's), and 2) enhanced patient tracking via improved management of registries/charts; * Adherence and retention package: 1) Creation of "Adherence Committees" at each site to coordinate and systematize patient follow-up, 2) active patient follow-up and home visits by community health workers (CHWs or activistas), 3) use of text messaging to patients by MCH nurses, 4) improved and intensified counseling coordinated with active CHW and text follow-up, and 5) intensified and improved Option B+ training and supportive supervision. | Other | Adherence and retention intervention |
Primary outcome
Retention at 30 days
Time frame: 45 days
The primary outcome measure for Aim 3 is the proportion of HIV-positive pregnant women tested at the participating ANC sites that successfully initiates appropriate ART and returns for their scheduled 30-day visit for pharmacy refill and evaluation within 45 days.
Adherence at 90 days
Time frame: 90 days
The primary outcome measure for Aim 4 is the ART adherence rate through 90 days after ART initiation.
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 10 May 2023.
- Derived from this study: PubMed 25924668Cowan JF, Micek M, Cowan JF, Napua M, Hoek R, Gimbel S, Gloyd S, Sherr K, Pfeiffer JT, Chapman RR. Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach. Implement Sci. 2015 Apr 30;10:61. doi: 10.1186/s13012-015-0249-6.
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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.
Rachel Chapman, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence and retention package in people with HIV, run by University of Washington at 1 site in Mozambique.
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 1 inclusion and 2 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mozambique. 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?
Retention at 30 days (time frame: 45 days). 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 NCT02371265, which also lists 1 linked publication.
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 10 May 2023.