HIV/AIDSNCT01891799
Swaziland Safe Generations
An observational study of HIV/AIDS, run by Columbia University at 12 sites in Eswatini.
Trial summary
The purpose of this study is to understand how best to provide care and treatment services to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Option B+
- How many people
- 2,518 participants
- Where
- 12 sitesEswatini
- Study dates
- Aug 2013to 30 Oct 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The target population for the PMTCT Options Evaluation is all HIV+ pregnant women not on ART at their first ANC visit at the 10 study facilities. A total of approximately 2600 mother-infant pairs (2600 HIV positive women + 2600 of their HIV exposed babies) will be observed.
Who may be able to join
- Women at least 18 years of age
- Documented pregnancy (per routine ANC protocol in this setting)
- Documented HIV-infection (per routine ANC protocol in this setting)
- Infants born to eligible and enrolled women
Who cannot join
- Women already on ART when entering ANC
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Eswatini12 sites
Family Life Association Clinic
Manzini
King Soghuza II PHU
Manzini
Lamvelase Clinic
Manzini
Luyengo Clinic
Manzini
Mankayane PHU
Manzini
Mbabane Government Hospital
Manzini
Mbikhwakhe Clinic
Manzini
MSF Matsapha
Manzini
Raleigh Fitkin Memorial Hospital
Manzini
Good Shepherd Hospital
Siteki, Lubombo Region
Siphofaneni
Siteki, Lubombo Region
Siteki PHU
Siteki, Lubombo Region
About this study
Official title: Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women
The purpose of this study is to understand how best to provide care and treatment services to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy regardless of their disease stage. The goal is to prevent delays in women accessing treatment for their own health and ensure that women and their children remain in care. This study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health facilities in the Manzini and Lubombo regions in Swaziland. The study has three components: the main component is a PMTCT Options Evaluation where data from medical records will be abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected study facilities; data will be abstracted on their HIV exposed infants as well. Other components of the study include a PMTCT Options Acceptability Evaluation using semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.
Read the detailed description
Purpose:
"Situkulwane Lesiphephile-Safe Generations" is an implementation science research study designed to evaluate an innovative PMTCT strategy that includes a modified Option B approach, where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy independent of CD4+ count (Option B+) and all HIV positive pregnant and postpartum women and their infants are engaged in the same structured appointment and follow-up protocols currently available only to women receiving antiretroviral therapy (ART). The study hypothesizes that this single, uniform and streamlined treatment and retention approach for all HIV positive pregnant women will eliminate delays, prevent losses and will: (1) result in a higher proportion of mothers and infants successfully completing the PMTCT cascade and fewer new pediatric infections; (2) lead to a higher proportion of ART-eligible women initiating triple ART earlier in pregnancy; (3) will be more feasible to implement; 4) have greater acceptability among staff and patients; and 5) will be more cost-effective compared to Option A.
Design:
Stepped wedge design at 10 health facilities with one facility transitioning from Option A to the Option B+ approach every month over 12 months. Outcome measures will be compared under Option A and Option B+ conditions for all sites as well as before and after the transition at each site. Routinely collected data from facility registers and medical records will be abstracted to determine study outcomes. In addition, two purposely selected cohorts of (1)120 PMTCT clients and; (2) approximately 50 health care workers will complete questionnaires at repeated time points to assess acceptability of Option A and Option B+ approaches.
Study Population:
All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be part of the PMTCT Options Evaluation. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the absolute neutrophil count (ANC). A subset of HIV+ pregnant women not on ART engaging in PMTCT services and health care workers providing PMTCT services at the study sites will be enrolled in an acceptability evaluation.
Study Size:
A total of approximately 2,600 HIV positive pregnant women enrolled in PMTCT services at ten Ministry of Health (MOH) facilities.
Primary Objective:
To compare the impact of implementing Option A and Option B+ on the composite endpoint of infant HIV-positive polymerase chain reaction (PCR) at 6 months postpartum or maternal loss to follow-up at 6 months postpartum.
Secondary Objectives:
- To compare Option A and Option B+ on proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy and on duration of ART received prior to delivery for ART-eligible pregnant women
- To compare Option A and Option B+ on the proportion of women and children retained in HIV care at 12, and 18 months postpartum
- To examine patient and provider level acceptability of Option A and Option B+
- To compare the cost-effectiveness of Option A and Option B+
Tertiary Objectives:
- To determine pregnancy and infant outcomes (including fetal losses, neonatal death, birth weight and gestational age) among HIV+ pregnant women receiving PMTCT and compare outcomes by maternal ARV regimens.
- To compare Option A and Option B+ on maternal and child adherence as measured by prescriptions dispensed for maternal and infant antiretroviral medications.
- Conditions
- HIV/AIDS
- Being tested
- Option B+
- Keywords
- HIV/AIDS, PMTCT, Option B+, Swaziland
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Option B+Other
- Using one low toxicity triple ARV regimen [(tenofovir (TDF) + lamivudine/emtricitabine (3TC/FTC) + efavirenz (EFV)] for all women, rather than adapting regimens by CD4+
- Engaging all pregnant and postpartum women and their infants in the structured appointment and follow-up system currently only available to women receiving ART
- Providing a simplified standardized public health approach both antenatally and postnatally, with adherence and retention support tailored to the particular health and social needs of peripartum women
| Study group | Role | What they receive |
|---|---|---|
| PMTCT Options Evaluation | All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be included. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the ANC. All women will eventually receive the intervention of Option B+ as each clinic transitions from Option A to B+. Receives: Other: Option B+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum
Combined maternal-child endpoint: The primary outcome will be measured on all HIV+ pregnant women not on ART at their first ANC visit at a participating study site, approximately 2600 women(becoming mother-infant pairs postpartum). This includes women entering PMTCT with known HIV+ status, not on ART, and women testing HIV+ on entry into ANC.
Measured: Up to 24 months
Secondary outcomes (3)
Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
ART Initiation During Pregnancy: Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
Measured: Up to 24 months
Proportion of women and children retained in HIV care at 12 and 18 months postpartum
Maternal/Infant Retention in Care: Proportion of women and children retained in HIV care at 12 and 18 months postpartum
Measured: Up to 24 months
Duration of ART/ARV received prior to delivery
ART/ARV Duration: Duration of ART/ARV received prior to delivery
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startAug 2013
- Primary completion30 Oct 2016
- Study completion30 Oct 2016
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 HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Health, Swaziland, University of Cape Town, Elizabeth Glaser Pediatric AIDS Foundation, National Emergency Response Council on HIV and AIDS (NERCHA)
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Elaine J Abrams, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891799
- Sponsor's protocol ID
- AAAL0661
- Other IDs
- AID-OAA-A-12-000020
- Status last verified
- Feb 2018
- First submitted
- 28 Jun 2013
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
DiCarlo AL, Gachuhi AB, Mthethwa-Hleta S, Shongwe S, Hlophe T, Peters ZJ, Zerbe A, Myer L, Langwenya N, Okello V, Sahabo R, Nuwagaba-Biribonwoha H, Abrams EJ. Healthcare worker experiences with Option B+ for prevention of mother-to-child HIV transmission in eSwatini: findings from a two-year follow-up study. BMC Health Serv Res. 2019 Apr 2;19(1):210. doi: 10.1186/s12913-019-3997-1.
PubMed 30940149
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Situkulwane Lesiphephile-Safe Generations: Improving Approaches to Antiretroviral Therapy for HIV-Positive Pregnant Women
- ClinicalTrials.gov ID
- NCT01891799
- Acronym / sponsor ID
- AAAL0661
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, PMTCT, Option B+, Swaziland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,518 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Health, Swaziland, University of Cape Town, Elizabeth Glaser Pediatric AIDS Foundation, National Emergency Response Council on HIV and AIDS (NERCHA)
- Study start
- Aug 2013
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 3 Jul 2013 (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 purpose of this study is to understand how best to provide care and treatment services to human immunodeficiency virus (HIV) positive pregnant women and their babies in Swaziland. The study is designed to evaluate a new approach for Preventing Mother-to-Child Transmission (PMTCT)where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy regardless of their disease stage. The goal is to prevent delays in women accessing treatment for their own health and ensure that women and their children remain in care. This study will compare this new approach to PMTCT, known as Option B+, to Option A, which is the current standard of care for PMTCT in Swaziland. The study will be conducted at 10 health facilities in the Manzini and Lubombo regions in Swaziland. The study has three components: the main component is a PMTCT Options Evaluation where data from medical records will be abstracted on all HIV positive pregnant women attending antenatal services at the 10 selected study facilities; data will be abstracted on their HIV exposed infants as well. Other components of the study include a PMTCT Options Acceptability Evaluation using semi-structured questionnaires with PMTCT clients and health care workers (HCWs) as well as a cost effectiveness evaluation comparing costs under conditions of Option A and Option B+.
Detailed description
Purpose:
"Situkulwane Lesiphephile-Safe Generations" is an implementation science research study designed to evaluate an innovative PMTCT strategy that includes a modified Option B approach, where all HIV positive pregnant women initiate lifelong triple antiretroviral (ARV) therapy independent of CD4+ count (Option B+) and all HIV positive pregnant and postpartum women and their infants are engaged in the same structured appointment and follow-up protocols currently available only to women receiving antiretroviral therapy (ART). The study hypothesizes that this single, uniform and streamlined treatment and retention approach for all HIV positive pregnant women will eliminate delays, prevent losses and will: (1) result in a higher proportion of mothers and infants successfully completing the PMTCT cascade and fewer new pediatric infections; (2) lead to a higher proportion of ART-eligible women initiating triple ART earlier in pregnancy; (3) will be more feasible to implement; 4) have greater acceptability among staff and patients; and 5) will be more cost-effective compared to Option A.
Design:
Stepped wedge design at 10 health facilities with one facility transitioning from Option A to the Option B+ approach every month over 12 months. Outcome measures will be compared under Option A and Option B+ conditions for all sites as well as before and after the transition at each site. Routinely collected data from facility registers and medical records will be abstracted to determine study outcomes. In addition, two purposely selected cohorts of (1)120 PMTCT clients and; (2) approximately 50 health care workers will complete questionnaires at repeated time points to assess acceptability of Option A and Option B+ approaches.
Study Population:
All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be part of the PMTCT Options Evaluation. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the absolute neutrophil count (ANC). A subset of HIV+ pregnant women not on ART engaging in PMTCT services and health care workers providing PMTCT services at the study sites will be enrolled in an acceptability evaluation.
Study Size:
A total of approximately 2,600 HIV positive pregnant women enrolled in PMTCT services at ten Ministry of Health (MOH) facilities.
Primary Objective:
To compare the impact of implementing Option A and Option B+ on the composite endpoint of infant HIV-positive polymerase chain reaction (PCR) at 6 months postpartum or maternal loss to follow-up at 6 months postpartum.
Secondary Objectives:
- To compare Option A and Option B+ on proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy and on duration of ART received prior to delivery for ART-eligible pregnant women
- To compare Option A and Option B+ on the proportion of women and children retained in HIV care at 12, and 18 months postpartum
- To examine patient and provider level acceptability of Option A and Option B+
- To compare the cost-effectiveness of Option A and Option B+
Tertiary Objectives:
- To determine pregnancy and infant outcomes (including fetal losses, neonatal death, birth weight and gestational age) among HIV+ pregnant women receiving PMTCT and compare outcomes by maternal ARV regimens.
- To compare Option A and Option B+ on maternal and child adherence as measured by prescriptions dispensed for maternal and infant antiretroviral medications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMTCT Options Evaluation | – | Other: Option B+All HIV positive pregnant women not on ART engaging in PMTCT services at the study sites will be included. This will include HIV+ women not on ART enrolling in PMTCT services and pregnant women newly testing HIV+ in the ANC. All women will eventually receive the intervention of Option B+ as each clinic transitions from Option A to B+. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for the PMTCT Options Evaluation is all HIV+ pregnant women not on ART at their first ANC visit at the 10 study facilities. A total of approximately 2600 mother-infant pairs (2600 HIV positive women + 2600 of their HIV exposed babies) will be observed.
Key inclusion criteria (4 listed)
- Women at least 18 years of age
- Documented pregnancy (per routine ANC protocol in this setting)
- Documented HIV-infection (per routine ANC protocol in this setting)
- Infants born to eligible and enrolled women
Key exclusion criteria (1 listed)
- Women already on ART when entering ANC
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 |
|---|---|---|
| Option B+* Using one low toxicity triple ARV regimen [(tenofovir (TDF) + lamivudine/emtricitabine (3TC/FTC) + efavirenz (EFV)] for all women, rather than adapting regimens by CD4+ * Engaging all pregnant and postpartum women and their infants in the structured appointment and follow-up system currently only available to women receiving ART * Providing a simplified standardized public health approach both antenatally and postnatally, with adherence and retention support tailored to the particular health and social needs of peripartum women | Other | PMTCT Options Evaluation |
Primary outcome
Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum
Time frame: Up to 24 months
Combined maternal-child endpoint: The primary outcome will be measured on all HIV+ pregnant women not on ART at their first ANC visit at a participating study site, approximately 2600 women(becoming mother-infant pairs postpartum). This includes women entering PMTCT with known HIV+ status, not on ART, and women testing HIV+ on entry into ANC.
3 secondary outcomes
Proportion of pregnant women with CD4+<350 cells/mm3 initiating ART during pregnancy
Time frame: Up to 24 months
Proportion of women and children retained in HIV care at 12 and 18 months postpartum
Time frame: Up to 24 months
Duration of ART/ARV received prior to delivery
Time frame: Up to 24 months
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 12 Feb 2018.
- Derived from this study: PubMed 30940149DiCarlo AL, Gachuhi AB, Mthethwa-Hleta S, Shongwe S, Hlophe T, Peters ZJ, Zerbe A, Myer L, Langwenya N, Okello V, Sahabo R, Nuwagaba-Biribonwoha H, Abrams EJ. Healthcare worker experiences with Option B+ for prevention of mother-to-child HIV transmission in eSwatini: findings from a two-year follow-up study. BMC Health Serv Res. 2019 Apr 2;19(1):210. doi: 10.1186/s12913-019-3997-1.
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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.
Elaine J Abrams, MD principal investigator
Columbia University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Columbia University at 12 sites in Eswatini.
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 4 inclusion and 1 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 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Eswatini. 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?
Number of (1) infant HIV positive PCR at six months postpartum OR (2) mother lost to follow-up from at six months postpartum (time frame: Up to 24 months). 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 NCT01891799, 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 12 Feb 2018.