HIVNCT02085356
Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples
A study testing Protect your family in people with HIV and Pregnancy, run by University of Miami at 1 site in South Africa.
Trial summary
This study will test the effectiveness of a behavioral intervention to increase Prevention of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Protect your family
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,967 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- HIV seropositive pregnant women with partners, 20-24 weeks pregnant (typical time of entry into antenatal clinic care), aged >18.
- In Phase 2 (couples phase), both women and their partners will be enrolled. For the purposes of this study, primary male partners are defined as 1) husband, 2) current baby's father, or 3) current sexual partner.
Who cannot join
- Persons actively psychotic (auditory or visual hallucination) or intoxicated (e.g., under the influence of alcohol of illegal drugs) will not be eligible and will be referred for treatment. Following resolution of symptoms, these persons will be eligible for the study. N.B.: Any person presenting for sessions actively psychotic or intoxicated will be referred for treatment and will not be eligible to participate in sessions until symptoms are resolved due to reduced likelihood of benefit from sessions.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Human Sciences Research Council
Pretoria, Gauteng, 0002
About this study
Official title: Implementing Comprehensive PMTCT and HIV Prevention for South African Couples
This study will test the effectiveness of a behavioral intervention to increase Prevention of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive pregnant women. This study will also determine whether the participation of male partners will have additional positive impact on PMTCT uptake. The intervention will utilize a combination of both gender-concordant groups and individual or couples counseling strategies, before and after birth. During antenatal care, the intervention will use a gender-concordant group format to address PMTCT information, HIV disclosure, coping with stigma, intimate partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and following birth, the intervention will shift to individual or couples-based counseling, targeting medication adherence, safer infant feeding, and family planning. It is hypothesized that women attending the intervention will be more likely to properly take HIV medication before birth and provide it to their infants. Additionally, it is hypothesized that male partner involvement will further increase the likelihood that mothers will take their HIV medication as prescribed and provide it to their infants.
Read the detailed description
Abstract. In rural South Africa, only two-thirds of HIV+ pregnant women seeking antenatal care at community health centers took full advantage of available "prevention of mother-to-child transmission" (PMTCT) services in 2010 (SADOH). While engagement of male partners has been encouraged as a potential means of increasing PMTCT uptake, men have been reluctant to accompany their wives/partners to antenatal care.
Recent studies generally support male involvement in promoting PMTCT, but the nature and impact of that involvement is unclear and untested. It is also clear that factors such as stigma, disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care, suggesting that male involvement may be "necessary, but not sufficient" to accomplish the WHO goal of <5% infant HIV incidence. Additional measures may be needed to increase participation by HIV positive pregnant women in PMTCT.
In 2011, Mpumalanga Province had the highest rates of HIV in the country (36.7%) and rates of infant HIV incidence in rural clinics ranged up to 50%. Rates of PMTCT uptake in the Province have been among the lowest in South Africa (69%). This application proposes to expand on a successful PEPFAR- supported, PMTCT couples intervention pilot study conducted in Mpumalanga Province, ("Vikela Umndeni: Protect Your Family") to include a more representative population of HIV positive pregnant women and their partners, the primary objective being to determine whether male partner involvement plus a behavioral intervention would significantly reduce infant HIV incidence by increasing levels of adherence to ARV/ PMTCT protocols, including breastfeeding and family planning, during the antenatal and post-natal periods.
The proposed study will enroll two cohorts of HIV positive pregnant women recruited from 12 randomly assigned Community Health Centers (6 experimental, 6 control): a) Women attending without their male partners (n = 720), followed by b) Women attending with their male partners (n = 720 couples), to determine whether the influence of male participation itself or combined with a behavioral PMTCT intervention can significantly reduce infant HIV infection ante-, peri- and post-natally. It is our intention to significantly increase PMTCT participation from current levels (69%) in Mpumalanga Province to 90-95% through engaging women and couples in a unique, controlled, six session ante- and post-natal risk-reducing/PMTCT promotion intervention addressing the barriers to PMTCT (e.g., stigma, disclosure, intimate partner violence, communication, infant feeding practices, safer conception) that prevent women and men from taking full advantage of the treatment opportunities available to them and their infants. Based upon the encouraging preliminary results from our pilot study, successful CHC adoption of the "Vikela Umndeni: Protect Your Family" program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa: HIV+ pregnant women and their infants.
- Being tested
- Protect your family
- Keywords
- HIV, PMTCT, South Africa, Couples, Male involvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protect your familyBehavioural
"Protect Your Family" intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.
Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)
| Study group | Role | What they receive |
|---|---|---|
| Intervention women with partners | Experimental | Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention Receives: Behavioral: Protect your family |
| Intervention women without partners | Experimental | Women will enroll alone and will attend the Protect your Family Intervention without a partner Receives: Behavioral: Protect your family |
| Control women with partners | No intervention | Women will enroll with male partners and both members of the couple will attend time-matched video sessions |
| Control women alone | No intervention | Women will enroll alone and will attend time-matched video sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dried Blood Spot Analysis of Medication Adherence- Mother and Infant
Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.
Measured: 32 weeks gestation
Infant HIV Seroconversions
Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol
Measured: 12 months postpartum
Secondary outcomes (2)
Mother Reported Rates of Infant Exclusive Breastfeeding
Feeding practices will be assessed at 6 weeks, and rates of exclusive breastfeeding will be assessed.
Measured: 6 weeks
Attendance at Scheduled Ante and Postnatal Clinic Appointments
Attendance at clinic appointments will be collected from patient records and self-report pre- and post-natal
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)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 MiamiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,967 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Human Sciences Research Council
- Responsible party
- Principal investigator, DEBORAH JONES, University of Miami
- Investigators
- Deborah L Jones, PhD, Principal investigator, University of MiamiKarl Peltzer, PhD, Principal investigator, Human Sciences Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085356
- Sponsor's protocol ID
- 20130238
- Other IDs
- 1R01HD078187
- Status last verified
- Jan 2019
- First submitted
- 10 Mar 2014
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Dissemination of findings will be made to the community participants and stakeholders. The US team and the South Africa team will collaborate and encourage community stakeholders to participate in dissemination and development of related research. Utilizing the data from this study, the collaborators will compile a research review document for the Government of South Africa. Successful results of this research will be used to develop a translational proposal based on empirical results. The study results will be disseminated through Dr. Peltzer, the South Africa PI. All investigators will work within the structure of the South Africa community sites to provide feedback to other medical providers and to the professional community by presentation of the results. Access to the database will be available under the supervision of the collaborators.
Publications
Peltzer K, Abbamonte JM, Soni M, Rodriguez VJ, Lee TK, Weiss SM, Jones DL. Psychological and physical intimate partner violence and sexual risk behavior among South African couples: a dyadic analysis. AIDS Care. 2022 Dec;34(12):1610-1618. doi: 10.1080/09540121.2021.2016576. Epub 2021 Dec 18.
PubMed 34927477Ramlagan S, Rodriguez VJ, Peltzer K, Ruiter RAC, Jones DL, Sifunda S. Self-Reported Long-Term Antiretroviral Adherence: A Longitudinal Study Among HIV Infected Pregnant Women in Mpumalanga, South Africa. AIDS Behav. 2019 Sep;23(9):2576-2587. doi: 10.1007/s10461-019-02563-z.
PubMed 31228026Sifunda S, Peltzer K, Rodriguez VJ, Mandell LN, Lee TK, Ramlagan S, Alcaide ML, Weiss SM, Jones DL. Impact of male partner involvement on mother-to-child transmission of HIV and HIV-free survival among HIV-exposed infants in rural South Africa: Results from a two phase randomised controlled trial. PLoS One. 2019 Jun 5;14(6):e0217467. doi: 10.1371/journal.pone.0217467. eCollection 2019.
PubMed 31166984Peltzer K, Babayigit S, Rodriguez VJ, Jean J, Sifunda S, Jones DL. Effect of a multicomponent behavioural PMTCT cluster randomised controlled trial on HIV stigma reduction among perinatal HIV positive women in Mpumalanga province, South Africa. SAHARA J. 2018 Dec;15(1):80-88. doi: 10.1080/17290376.2018.1510787.
PubMed 30134772Jones DL, Rodriguez VJ, Mandell LN, Lee TK, Weiss SM, Peltzer K. Influences on Exclusive Breastfeeding Among Rural HIV-Infected South African Women: A Cluster Randomized Control Trial. AIDS Behav. 2018 Sep;22(9):2966-2977. doi: 10.1007/s10461-018-2197-z.
PubMed 29926300Peltzer K, Weiss SM, Soni M, Lee TK, Rodriguez VJ, Cook R, Alcaide ML, Setswe G, Jones DL. A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa. AIDS Res Ther. 2017 Dec 16;14(1):61. doi: 10.1186/s12981-017-0187-2.
PubMed 29248014Jones D, Peltzer K, Weiss SM, Sifunda S, Dwane N, Ramlagan S, Cook R, Matseke G, Maduna V, Spence A. Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial. Trials. 2014 Oct 27;15:417. doi: 10.1186/1745-6215-15-417.
PubMed 25348459
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Comprehensive PMTCT and HIV Prevention for South African Couples
- ClinicalTrials.gov ID
- NCT02085356
- Acronym / sponsor ID
- 20130238
- Keywords
- HIV, PMTCT, South Africa, Couples, Male involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,967 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Human Sciences Research Council
- Study start
- Apr 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Posted 21 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of a behavioral intervention to increase Prevention of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive pregnant women. This study will also determine whether the participation of male partners will have additional positive impact on PMTCT uptake. The intervention will utilize a combination of both gender-concordant groups and individual or couples counseling strategies, before and after birth. During antenatal care, the intervention will use a gender-concordant group format to address PMTCT information, HIV disclosure, coping with stigma, intimate partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and following birth, the intervention will shift to individual or couples-based counseling, targeting medication adherence, safer infant feeding, and family planning. It is hypothesized that women attending the intervention will be more likely to properly take HIV medication before birth and provide it to their infants. Additionally, it is hypothesized that male partner involvement will further increase the likelihood that mothers will take their HIV medication as prescribed and provide it to their infants.
Detailed description
Abstract. In rural South Africa, only two-thirds of HIV+ pregnant women seeking antenatal care at community health centers took full advantage of available "prevention of mother-to-child transmission" (PMTCT) services in 2010 (SADOH). While engagement of male partners has been encouraged as a potential means of increasing PMTCT uptake, men have been reluctant to accompany their wives/partners to antenatal care.
Recent studies generally support male involvement in promoting PMTCT, but the nature and impact of that involvement is unclear and untested. It is also clear that factors such as stigma, disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care, suggesting that male involvement may be "necessary, but not sufficient" to accomplish the WHO goal of <5% infant HIV incidence. Additional measures may be needed to increase participation by HIV positive pregnant women in PMTCT.
In 2011, Mpumalanga Province had the highest rates of HIV in the country (36.7%) and rates of infant HIV incidence in rural clinics ranged up to 50%. Rates of PMTCT uptake in the Province have been among the lowest in South Africa (69%). This application proposes to expand on a successful PEPFAR- supported, PMTCT couples intervention pilot study conducted in Mpumalanga Province, ("Vikela Umndeni: Protect Your Family") to include a more representative population of HIV positive pregnant women and their partners, the primary objective being to determine whether male partner involvement plus a behavioral intervention would significantly reduce infant HIV incidence by increasing levels of adherence to ARV/ PMTCT protocols, including breastfeeding and family planning, during the antenatal and post-natal periods.
The proposed study will enroll two cohorts of HIV positive pregnant women recruited from 12 randomly assigned Community Health Centers (6 experimental, 6 control): a) Women attending without their male partners (n = 720), followed by b) Women attending with their male partners (n = 720 couples), to determine whether the influence of male participation itself or combined with a behavioral PMTCT intervention can significantly reduce infant HIV infection ante-, peri- and post-natally. It is our intention to significantly increase PMTCT participation from current levels (69%) in Mpumalanga Province to 90-95% through engaging women and couples in a unique, controlled, six session ante- and post-natal risk-reducing/PMTCT promotion intervention addressing the barriers to PMTCT (e.g., stigma, disclosure, intimate partner violence, communication, infant feeding practices, safer conception) that prevent women and men from taking full advantage of the treatment opportunities available to them and their infants. Based upon the encouraging preliminary results from our pilot study, successful CHC adoption of the "Vikela Umndeni: Protect Your Family" program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa: HIV+ pregnant women and their infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention women with partners | Experimental | Behavioral: Protect your familyWomen will enroll with male partners and both members of the couple will attend the Protect your Family intervention |
| Intervention women without partners | Experimental | Behavioral: Protect your familyWomen will enroll alone and will attend the Protect your Family Intervention without a partner |
| Control women with partners | No intervention | –Women will enroll with male partners and both members of the couple will attend time-matched video sessions |
| Control women alone | No intervention | –Women will enroll alone and will attend time-matched video sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV seropositive pregnant women with partners, 20-24 weeks pregnant (typical time of entry into antenatal clinic care), aged >18.
- In Phase 2 (couples phase), both women and their partners will be enrolled. For the purposes of this study, primary male partners are defined as 1) husband, 2) current baby's father, or 3) current sexual partner.
Key exclusion criteria (1 listed)
- Persons actively psychotic (auditory or visual hallucination) or intoxicated (e.g., under the influence of alcohol of illegal drugs) will not be eligible and will be referred for treatment. Following resolution of symptoms, these persons will be eligible for the study. N.B.: Any person presenting for sessions actively psychotic or intoxicated will be referred for treatment and will not be eligible to participate in sessions until symptoms are resolved due to reduced likelihood of benefit from sessions.
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 |
|---|---|---|
| Protect your family"Protect Your Family" intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use. Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT) | Behavioural | Intervention women with partners, Intervention women without partners |
Primary outcome
Dried Blood Spot Analysis of Medication Adherence- Mother and Infant
Time frame: 32 weeks gestation
Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.
Infant HIV Seroconversions
Time frame: 12 months postpartum
Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol
2 secondary outcomes
Mother Reported Rates of Infant Exclusive Breastfeeding
Time frame: 6 weeks
Attendance at Scheduled Ante and Postnatal Clinic Appointments
Time frame: 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34927477Peltzer K, Abbamonte JM, Soni M, Rodriguez VJ, Lee TK, Weiss SM, Jones DL. Psychological and physical intimate partner violence and sexual risk behavior among South African couples: a dyadic analysis. AIDS Care. 2022 Dec;34(12):1610-1618. doi: 10.1080/09540121.2021.2016576. Epub 2021 Dec 18.
- Derived from this study: PubMed 31228026Ramlagan S, Rodriguez VJ, Peltzer K, Ruiter RAC, Jones DL, Sifunda S. Self-Reported Long-Term Antiretroviral Adherence: A Longitudinal Study Among HIV Infected Pregnant Women in Mpumalanga, South Africa. AIDS Behav. 2019 Sep;23(9):2576-2587. doi: 10.1007/s10461-019-02563-z.
- Derived from this study: PubMed 31166984Sifunda S, Peltzer K, Rodriguez VJ, Mandell LN, Lee TK, Ramlagan S, Alcaide ML, Weiss SM, Jones DL. Impact of male partner involvement on mother-to-child transmission of HIV and HIV-free survival among HIV-exposed infants in rural South Africa: Results from a two phase randomised controlled trial. PLoS One. 2019 Jun 5;14(6):e0217467. doi: 10.1371/journal.pone.0217467. eCollection 2019.
- Derived from this study: PubMed 30134772Peltzer K, Babayigit S, Rodriguez VJ, Jean J, Sifunda S, Jones DL. Effect of a multicomponent behavioural PMTCT cluster randomised controlled trial on HIV stigma reduction among perinatal HIV positive women in Mpumalanga province, South Africa. SAHARA J. 2018 Dec;15(1):80-88. doi: 10.1080/17290376.2018.1510787.
- Derived from this study: PubMed 29926300Jones DL, Rodriguez VJ, Mandell LN, Lee TK, Weiss SM, Peltzer K. Influences on Exclusive Breastfeeding Among Rural HIV-Infected South African Women: A Cluster Randomized Control Trial. AIDS Behav. 2018 Sep;22(9):2966-2977. doi: 10.1007/s10461-018-2197-z.
- Derived from this study: PubMed 29248014Peltzer K, Weiss SM, Soni M, Lee TK, Rodriguez VJ, Cook R, Alcaide ML, Setswe G, Jones DL. A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa. AIDS Res Ther. 2017 Dec 16;14(1):61. doi: 10.1186/s12981-017-0187-2.
- Derived from this study: PubMed 25348459Jones D, Peltzer K, Weiss SM, Sifunda S, Dwane N, Ramlagan S, Cook R, Matseke G, Maduna V, Spence A. Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial. Trials. 2014 Oct 27;15:417. doi: 10.1186/1745-6215-15-417.
- Individual participant dataSharing planned: Yes. Dissemination of findings will be made to the community participants and stakeholders. The US team and the South Africa team will collaborate and encourage community stakeholders to participate in dissemination and development of related research. Utilizing the data from this study, the collaborators will compile a research review document for the Government of South Africa. Successful results of this research will be used to develop a translational proposal based on empirical results. The study results will be disseminated through Dr. Peltzer, the South Africa PI. All investigators will work within the structure of the South Africa community sites to provide feedback to other medical providers and to the professional community by presentation of the results. Access to the database will be available under the supervision of the collaborators.
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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.
Deborah L Jones, PhD principal investigator
University of Miami
Karl Peltzer, PhD principal investigator
Human Sciences Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protect your family in people with HIV and Pregnancy, run by University of Miami at 1 site 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 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 21 Feb 2019. 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 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?
Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dried Blood Spot Analysis of Medication Adherence- Mother and Infant (time frame: 32 weeks gestation). 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 NCT02085356, which also lists 7 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 21 Feb 2019.