HIVSAFINCT03023033
Supporting Attendance for Facility Delivery and Infant Health
A study testing mHealth messaging and Transport Payments in people with HIV and AIDS, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Tanzania.
Trial summary
The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- mHealth messaging and Transport Payments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,505 participants
- Where
- 1 siteTanzania
- Study dates
- Oct 2014to Nov 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
- Plans to deliver in facility catchment area
- 18 years or older
- Able and willing to provide consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.
Read the detailed description
Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, [mobile health or mhealth] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).
- Being tested
- mHealth messaging, Transport Payments
- Keywords
- PMTCT, MNCH
- 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.
mHealth messagingBehavioural
SMS appointment reminders and health messaging via mobile phones
Transport PaymentsBehavioural
A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area
| Study group | Role | What they receive |
|---|---|---|
| Clinic group 1 | Experimental | Clinics using SMS health promotion and reminder messages (mhealth messaging) Receives: Behavioral: mHealth messaging |
| Clinic group 2 | Experimental | Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments) Receives: Behavioral: Transport Payments |
| Clinic group 3 | No intervention | Services provided under the Ministry of Health standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance for Early infant diagnosis (EID) of HIV
Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks
Measured: 1 year
Early identification of HEI at Reproductive and Child Health (RCH) Clinic
Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic
Measured: 1 year
Antenatal care (ANC) visits
Proportion of pregnant women attending at least 4 ANC visits
Measured: 1 year
Facility delivery
Proportion of pregnant women delivering in a health facility
Measured: 1 year
Post natal care (PNC) visits
Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery
Measured: 1 year
Nevirapine (NVP) at delivery
Proportion of HEI given NVP at delivery
Measured: 1 year
Secondary outcomes (5)
Receipt of EID results
Proportion of HEI who received EID results by 12 weeks
Measured: 1 year
HIV infected infants initiated on antiretroviral therapy (ART)
Proportion of HIV infected infants initiated on ART by 12 weeks of age
Measured: 1 year
Time to EID
Time (days/weeks) from date of birth to attendance for EID
Measured: 1 year
Time to receipt of EID results
Time (days/weeks) from date of birth to receipt of EID results
Measured: 1 year
Time to treatment
Time (days/weeks) from date of birth to initiation of ART
Measured: ! year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionNov 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 HIVStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council, Ministry of Health, Tanzania
- Responsible party
- Sponsor
- Investigators
- Godfrey Woelk, MCOMMH, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023033
- Sponsor's protocol ID
- EG0130
- Acronym
- SAFI
- Status last verified
- Feb 2021
- First submitted
- 27 Feb 2015
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018
Publications
Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
PubMed 32813276
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
- ClinicalTrials.gov ID
- NCT03023033
- Acronym / sponsor ID
- SAFI / EG0130
- Keywords
- PMTCT, MNCH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,505 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Population Council, Ministry of Health, Tanzania
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Jan 2017 (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 goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.
Detailed description
Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, [mobile health or mhealth] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic group 1 | Experimental | Behavioral: mHealth messagingClinics using SMS health promotion and reminder messages (mhealth messaging) |
| Clinic group 2 | Experimental | Behavioral: Transport PaymentsClinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments) |
| Clinic group 3 | No intervention | –Services provided under the Ministry of Health standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
- Plans to deliver in facility catchment area
- 18 years or older
- Able and willing to provide consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| mHealth messagingSMS appointment reminders and health messaging via mobile phones | Behavioural | Clinic group 1 |
| Transport PaymentsA payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area | Behavioural | Clinic group 2 |
Primary outcome
Attendance for Early infant diagnosis (EID) of HIV
Time frame: 1 year
Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks
Early identification of HEI at Reproductive and Child Health (RCH) Clinic
Time frame: 1 year
Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic
Antenatal care (ANC) visits
Time frame: 1 year
Proportion of pregnant women attending at least 4 ANC visits
Facility delivery
Time frame: 1 year
Proportion of pregnant women delivering in a health facility
Post natal care (PNC) visits
Time frame: 1 year
Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery
Nevirapine (NVP) at delivery
Time frame: 1 year
Proportion of HEI given NVP at delivery
5 secondary outcomes
Receipt of EID results
Time frame: 1 year
HIV infected infants initiated on antiretroviral therapy (ART)
Time frame: 1 year
Time to EID
Time frame: 1 year
Time to receipt of EID results
Time frame: 1 year
Time to treatment
Time frame: ! year
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 8 Feb 2021.
- Derived from this study: PubMed 32813276Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Individual participant dataSharing planned: Yes. The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018
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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.
Godfrey Woelk, MCOMMH, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth messaging and Transport Payments in people with HIV and AIDS, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Tanzania.
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 8 Feb 2021. 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 Tanzania. 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?
Attendance for Early infant diagnosis (EID) of HIV (time frame: 1 year). The study lists 6 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 NCT03023033, 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 8 Feb 2021.