Suspected Damage to Fetus From Viral Disease in the MotherNCT01805752
Optimizing Integrated PMTCT Services in Rural North-Central Nigeria
A study testing Task-shifting to lower-cadre providers at PMTCT sites, POC CD4+ cell count testing and integrated mother-infant care in people with Suspected Damage to Fetus From Viral Disease in the Mother and HIV, run by Vanderbilt University at 12 sites in 2 countries.
Trial summary
Each year, an estimated 230,000 HIV-infected women in need of services for prevention of mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other nation in the world. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suspected Damage to Fetus From Viral Disease in the Mother, HIV
- What is being tested?
- Task-shifting to lower-cadre providers at PMTCT sites, POC CD4+ cell count testing and integrated mother-infant care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Mar 2013to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status;
- HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery.
Who cannot join
- HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Nigeria11 sites
CHC Agwara
Agwara, Niger State
Rural Hospital
Auna, Niger State
MCH Chanchaga
Chanchaga, Niger State
NCWS Farin Doki
Farin Doki, Niger State
BHC Garam
Garam, Niger State
PHC Gauraka
Gauraka, Niger State
BHC Ijah
Ijah, Niger State
BHC Izom
Izom, Niger State
Rural Hospital
Kaffin Koro, Niger State
MCH Paiko
Paiko, Niger State
BHC Wuse
Sabon Wuse, Niger State
About this study
Official title: Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
Each year, an estimated 230,000 HIV-infected women in need of services for prevention of mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites are predominantly rural primary health centers (PHCs) where shortages of high-cadre health care providers and insufficient laboratory capacity to perform CD4+ cell count testing have been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing will facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these rural, decentralized sites. A system wherein men are facilitated to accompany their wives to ANC appointments will create an important opportunity to address entrenched gender norms. The investigators therefore propose using community and facility-based measures to encourage male partners to accompany their spouses for ANC. As influential community members, male partners can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT care provided by lower-cadre providers in these resource-constrained settings.
The investigators propose a parallel, cluster randomized trial to evaluate the impact of a family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers. The specific aims of this study are:
Read more
- To evaluate whether implementation of the integrated PMTCT package in primary level antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that the provision of the PMTCT package in intervention clinics will improve PMTCT antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%.
- To determine whether implementation of the PMTCT package improves postpartum retention of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum retention rates among mother-infant pairs attending intervention sites will be >20% higher at 6 weeks when compared to mother-infant pairs receiving care in non-intervention sites.
- Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT intervention compared to the existing standard-of-care referral model. The investigators hypothesize that the proposed intervention will be more cost-effective than the existing model of care.
In addition, two qualitative evaluations will be conducted in order to:
- Assess client satisfaction with health services, comparing PMTCT services provided by lower level vs. higher level cadre health workers; and
- Evaluate health care worker satisfaction with the new PMTCT service delivery model.
Read the detailed description
The investigators propose a parallel cluster randomized trial to evaluate the effects of the intervention. Twelve primary and secondary level health care facilities in Niger State will be randomized to the control (standard-of-care) or intervention arms. The investigators will match clinics on patient volume and level of facility and randomize to intervention and standard-of-care/control arms - 6 clinics per arm.
The investigators will make the proposed intervention available to all eligible women attending clinics that are randomized to the intervention arm. The drug regimens and general HIV care services provided as part of the package are standard of care, based on Nigerian national guidelines.
Inclusion Criteria: (1) HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status; (2) HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery.
Exclusion Criteria: HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC.
Home-based care (HBC) workers will track clients who miss appointments at control and intervention sites. The HBC workers will document clients as terminated care if they: (1) discontinued services due to death or personal decision; (2) transferred their care to another clinic; or (3) are lost to follow-up (defined as being 90 days late for a clinic appointment plus 5 failed attempts at tracking the client). Clients will not receive any remuneration for participating in the study. Clients will be allowed to discontinue participation and decide that their medical data cannot be used in the analysis.
- Being tested
- Task-shifting to lower-cadre providers at PMTCT sites, POC CD4+ cell count testing, integrated mother-infant care, Prominent role for influential family members (male partners) in collaboration with CHWs
- Keywords
- Prevention of mother to child HIV transmission, HIV/AIDS
- 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.
Task-shifting to lower-cadre providers at PMTCT sitesOther
POC CD4+ cell count testingOther
integrated mother-infant careOther
Prominent role for influential family members (male partners) in collaboration with CHWsOther
| Study group | Role | What they receive |
|---|---|---|
| Integrated family-focused PMTCT arm | Experimental | Intervention package includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers.
Patients attending sites randomized to this arm will also receive group health education; opt-out HIV testing, same-day HIV test results; infant feeding counseling; HBC services; infant prophylaxis, early infant diagnosis, and linkage to family spacing services, if desired. Receives: Other: Task-shifting to lower-cadre providers at PMTCT sites; Other: POC CD4+ cell count testing; Other: integrated mother-infant care; Other: Prominent role for influential family members (male partners) in collaboration with CHWs |
| Standard of care | No intervention | Arm will receive standard of care activities, namely: group health education; opt-out HIV testing, same-day HIV test results; infant feeding counseling; HBC services; infant prophylaxis, early infant diagnosis, linkage to family spacing services, if desired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible pregnant women who initiate ART for purposes of PMTCT
The primary outcome is the proportion of eligible women who initiate ARV medications for PMTCT. This will be determined through data in our electronic medical records system. The investigators will report the total proportion of women who initiate ARV drugs, presenting the results stratified by regimen (cART, ZDV, NVP) and type of facility. The investigators will also collect information on duration of cART.
Measured: 18 months
Secondary outcomes (1)
Postpartum retention of mother-infant pairs at 6 and 12 weeks post delivery
Mother-infant pairs who have presented for their 6-week postpartum appointment will be considered active in the program (retained in care). The investigators will assess retention at both 6 week and 12-week time points in order to examine the impact of our intervention package on early (6 week) and later (12-week) postpartum retention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suspected Damage to Fetus From Viral Disease in the MotherStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Muktar Aliyu, Vanderbilt University
- Investigators
- Muktar H Aliyu, MBBS, DrPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805752
- Sponsor's protocol ID
- 1R01HD075075-01
- Status last verified
- Nov 2016
- First submitted
- 4 Mar 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be available to other researchers.
Publications
Aliyu MH, Blevins M, Audet C, Shepherd BE, Hassan A, Onwujekwe O, Gebi UI, Kalish M, Lindegren ML, Vermund SH, Wester CW. Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study. Contemp Clin Trials. 2013 Sep;36(1):187-97. doi: 10.1016/j.cct.2013.06.013. Epub 2013 Jun 29.
PubMed 23816493Aliyu MH, Blevins M, Audet CM, Kalish M, Gebi UI, Onwujekwe O, Lindegren ML, Shepherd BE, Wester CW, Vermund SH. Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial. Lancet HIV. 2016 May;3(5):e202-11. doi: 10.1016/S2352-3018(16)00018-7. Epub 2016 Feb 24.
PubMed 27126487
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01805752
- Acronym / sponsor ID
- 1R01HD075075-01
- Keywords
- Prevention of mother to child HIV transmission, HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Mar 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.
Each year, an estimated 230,000 HIV-infected women in need of services for prevention of mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites are predominantly rural primary health centers (PHCs) where shortages of high-cadre health care providers and insufficient laboratory capacity to perform CD4+ cell count testing have been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing will facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these rural, decentralized sites. A system wherein men are facilitated to accompany their wives to ANC appointments will create an important opportunity to address entrenched gender norms. The investigators therefore propose using community and facility-based measures to encourage male partners to accompany their spouses for ANC. As influential community members, male partners can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT care provided by lower-cadre providers in these resource-constrained settings.
The investigators propose a parallel, cluster randomized trial to evaluate the impact of a family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers. The specific aims of this study are:
- To evaluate whether implementation of the integrated PMTCT package in primary level antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that the provision of the PMTCT package in intervention clinics will improve PMTCT antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%.
- To determine whether implementation of the PMTCT package improves postpartum retention of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum retention rates among mother-infant pairs attending intervention sites will be >20% higher at 6 weeks when compared to mother-infant pairs receiving care in non-intervention sites.
- Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT intervention compared to the existing standard-of-care referral model. The investigators hypothesize that the proposed intervention will be more cost-effective than the existing model of care.
In addition, two qualitative evaluations will be conducted in order to:
- Assess client satisfaction with health services, comparing PMTCT services provided by lower level vs. higher level cadre health workers; and
- Evaluate health care worker satisfaction with the new PMTCT service delivery model.
Detailed description
The investigators propose a parallel cluster randomized trial to evaluate the effects of the intervention. Twelve primary and secondary level health care facilities in Niger State will be randomized to the control (standard-of-care) or intervention arms. The investigators will match clinics on patient volume and level of facility and randomize to intervention and standard-of-care/control arms - 6 clinics per arm.
The investigators will make the proposed intervention available to all eligible women attending clinics that are randomized to the intervention arm. The drug regimens and general HIV care services provided as part of the package are standard of care, based on Nigerian national guidelines.
Inclusion Criteria: (1) HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status; (2) HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery.
Exclusion Criteria: HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC.
Home-based care (HBC) workers will track clients who miss appointments at control and intervention sites. The HBC workers will document clients as terminated care if they: (1) discontinued services due to death or personal decision; (2) transferred their care to another clinic; or (3) are lost to follow-up (defined as being 90 days late for a clinic appointment plus 5 failed attempts at tracking the client). Clients will not receive any remuneration for participating in the study. Clients will be allowed to discontinue participation and decide that their medical data cannot be used in the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated family-focused PMTCT arm | Experimental | Other: Task-shifting to lower-cadre providers at PMTCT sites, Other: POC CD4+ cell count testing, Other: integrated mother-infant care, Other: Prominent role for influential family members (male partners) in collaboration with CHWsIntervention package includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers. Patients attending sites randomized to this arm will also receive group health education; opt-out HIV testing, same-day HIV test results; infant feeding counseling; HBC services; infant prophylaxis, early infant diagnosis, and linkage to family spacing services, if desired. |
| Standard of care | No intervention | –Arm will receive standard of care activities, namely: group health education; opt-out HIV testing, same-day HIV test results; infant feeding counseling; HBC services; infant prophylaxis, early infant diagnosis, linkage to family spacing services, if desired. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status;
- HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery.
Key exclusion criteria (1 listed)
- HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to 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 |
|---|---|---|
| Task-shifting to lower-cadre providers at PMTCT sites | Other | Integrated family-focused PMTCT arm |
| POC CD4+ cell count testing | Other | Integrated family-focused PMTCT arm |
| integrated mother-infant care | Other | Integrated family-focused PMTCT arm |
| Prominent role for influential family members (male partners) in collaboration with CHWs | Other | Integrated family-focused PMTCT arm |
Primary outcome
Proportion of eligible pregnant women who initiate ART for purposes of PMTCT
Time frame: 18 months
The primary outcome is the proportion of eligible women who initiate ARV medications for PMTCT. This will be determined through data in our electronic medical records system. The investigators will report the total proportion of women who initiate ARV drugs, presenting the results stratified by regimen (cART, ZDV, NVP) and type of facility. The investigators will also collect information on duration of cART.
1 secondary outcome
Postpartum retention of mother-infant pairs at 6 and 12 weeks post delivery
Time frame: 12 weeks
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 2 Nov 2016.
- Background: PubMed 23816493Aliyu MH, Blevins M, Audet C, Shepherd BE, Hassan A, Onwujekwe O, Gebi UI, Kalish M, Lindegren ML, Vermund SH, Wester CW. Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study. Contemp Clin Trials. 2013 Sep;36(1):187-97. doi: 10.1016/j.cct.2013.06.013. Epub 2013 Jun 29.
- Derived from this study: PubMed 27126487Aliyu MH, Blevins M, Audet CM, Kalish M, Gebi UI, Onwujekwe O, Lindegren ML, Shepherd BE, Wester CW, Vermund SH. Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial. Lancet HIV. 2016 May;3(5):e202-11. doi: 10.1016/S2352-3018(16)00018-7. Epub 2016 Feb 24.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers.
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.
Muktar H Aliyu, MBBS, DrPH principal investigator
Vanderbilt University
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-shifting to lower-cadre providers at PMTCT sites, POC CD4+ cell count testing and integrated mother-infant care in people with Suspected Damage to Fetus From Viral Disease in the Mother and HIV, run by Vanderbilt University at 12 sites in 2 countries.
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 2 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 2 Nov 2016. 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 Nigeria, Niger. 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 of eligible pregnant women who initiate ART for purposes of PMTCT (time frame: 18 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 NCT01805752, which also lists 2 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 2 Nov 2016.