Human Immunodeficiency VirusMOTIVATE!NCT02491177
Mother and Infant Visit Adherence and Treatment Engagement Study
A study testing cMM and Text Messaging in people with Human Immunodeficiency Virus, run by University of Colorado, Denver at 1 site in Kenya.
Trial summary
This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- cMM and Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,338 participants
- Where
- 1 siteKenya
- Study dates
- May 2014to Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older,
- HIV-infected pregnant women and their HIV-exposed infants pairs,
- attends the antenatal care (ANC) clinic at one of the study sites.
Who cannot join
- Less than 18 years of age,
- HIV-infected women not currently pregnant,
- not HIV-infected at the time of the first ANC visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.
Read the detailed description
In order to eliminate new pediatric HIV infections, save maternal lives, and simplify antiretroviral therapy (ART) implementation in settings with generalized HIV epidemics, current World Health Organization (WHO) guidance recommends lifelong triple ART for all pregnant and breastfeeding women (Option B+). However, despite the promise of Option B+ to remove logistical barriers and to promote maternal health through life-long ART, this strategy brings challenges. Key amongst these challenges are adherence to ART and continuous retention in HIV care, especially for women who do not require ART for their own health. Barriers to adherence and retention in care for prevention of mother-to-child transmission (PMTCT) have been identified at the individual, interpersonal, community, and health facility levels; yet specific barriers in the context of Option B+ are not well understood. The investigators' study will be conducted at 20 health facilities and associated communities in Nyanza Province, Kenya where Mother to Child Transmission (MTCT) rates prior to Option B+ roll-out remained near 10%, despite the wide availability of PMTCT services. As Option B+ is scaled up in Kenya, it is essential to identify effective methods to ensure long-term adherence and retention in care for mother-baby pairs, throughout pregnancy, breastfeeding, and beyond. Building on the investigating team's prior research experience in this setting, the investigators propose to gain understanding of and address potential barriers at the individual, community, and health facility levels through formative research with HIV-positive pregnant and postpartum women, their male partners, and health care providers. This information will be used to refine two proposed interventions that are highly likely to maximize ART adherence and retention in care among HIV-infected pregnant women and HIV-exposed infants. These interventions will be rigorously tested in rural Kenya, using a cluster randomized 2x2 factorial design. The evidence-based interventions to be tested will include 1) community Mentor Mothers (cMM) who will provide support for ART adherence and retention in care for HIV-positive women in the community and 2) individually tailored, theory based mobile phone text messages to help retain women and infants in HIV care. The investigators' overall goal is to determine which intervention (or combination of interventions) maximizes ART adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes. The investigators' primary outcomes will include ART adherence at 12 months postpartum and retention in care, measured by a documented HIV care visit within 90 days prior to 12 months postpartum. Secondary outcomes will include MTCT at 6 weeks, 12 months and 18 months; as well as maternal viral loads and CD4 counts. Results from this study will inform the scale-up of Option B+ in Kenya by identifying effective interventions and combinations of interventions that can reduce barriers and increase facilitators of optimal ART adherence and retention in care with the aims of reaching the elimination of mother to child transmission of HIV and significantly improving maternal health.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- cMM, Text Messaging
- Keywords
- HIV Transmission, Prevention of Mother to Child Transmission, Linkage to care, Retention in care, Community Mentor Mothers, Mobile phone text messaging, Antiretroviral therapy adherence, Infant Health, Maternal CD4/viral loads, Early infant diagnosis, Acceptability of interventions, Vertical transmission
- 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.
cMMBehavioural
Home visits from community mentor mothers
Text MessagingBehavioural
Text messages received on mobile phone
| Study group | Role | What they receive |
|---|---|---|
| cMM and Text Messaging | Other | Participants randomized to this arm will receive both the community mentor mother and mobile phone text messaging intervention. The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language. Receives: Behavioral: cMM; Behavioral: Text Messaging |
| cMM Only | Other | Participants randomized to this arm will receive the community mentor mother intervention only.The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. Receives: Behavioral: cMM |
| Text Messaging Only | Other | Participants randomized to this arm will receive the mobile phone text messaging intervention only. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language. Receives: Behavioral: Text Messaging |
| Neither cMM nor Text Messaging | No intervention | Participants randomized to this arm will receive standard of care with no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported adherence on antiretroviral therapy
Self-report
Measured: 12 months post-partum
Adherence on antiretroviral therapy
Viral load<100 copies/ml based on medical records
Measured: 12 months post-partum
Adherence on antiretroviral therapy (infant)
Use of ARVs for the infant
Measured: 12 months post-partum
Retention in care
Proportion of women who have an HIV care visit within 90 days at 12 months after the birth
Measured: 12 months post-partum
Adherence on antiretroviral therapy (dried blood spots)
Viral load<100 copies/ml based on dried blood spots
Measured: 12 months post-partum
Secondary outcomes (13)
Maternal CD4 count change
Change in CD4 count baseline to 6 months after baseline
Measured: 6 months after baseline
Maternal viral load count change
Change in viral load from baseline to 6 months after baseline
Measured: 6 months after baseline
Infant retention in care (feeding method)
Infant feeding method
Measured: 12 and 18 months
Infant retention in care
Retention in care through 12 and 18 months
Measured: 12 and 18 months
Infant retention in care (survival status)
Survival status of infant
Measured: 12 and 18 months
Uptake of intervention services (Number/types of text messages sent)
Number/types of text messages sent
Measured: 3 years
Uptake of intervention services (receipt of text messages)
Receipt of text messages
Measured: 3 years
Uptake of intervention services (home visits)
Number of home visits received
Measured: 3 years
Uptake of intervention services (support groups attended)
Number of support groups attended.
Measured: 3 years
Mother-to-Child-Transmission
Result of infant HIV test at 6 wks, 9,18 months
Measured: 6 weeks, 9 months and 18 months
Infant testing
Uptake and date of infant testing
Measured: 6 weeks, 9 months and 18 months
Infant enrollment in care
Infant enrollment in HIV care
Measured: 6 weeks
Male partner involvement
Composite variable including Y/N response to indicate if male partner attended a health visit with his female partner, encouraged facility delivery, reminded to take HIV medication, reminded to go for HIV care, provided transport money to go to the clinic/dispensary, reminded to give the infant prophylaxis, helped giving the infant prophylaxis medication, collected medication for the woman or infant, encouraged specific infant feeding, and encouraged pediatric HIV testing. These are assessed in the follow-up questionnaires completed at 12 months post-partum.
Measured: 12 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionApr 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lisa Abuogi, MD, MSc, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491177
- Sponsor's protocol ID
- 14-0331
- Other IDs
- R01HD080477-01
- Acronym
- MOTIVATE!
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2015
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abuogi LL, Onono M, Odeny TA, Owuor K, Helova A, Hampanda K, Odwar T, Onyango D, McClure LA, Bukusi EA, Turan JM. Effects of behavioural interventions on postpartum retention and adherence among women with HIV on lifelong ART: the results of a cluster randomized trial in Kenya (the MOTIVATE trial). J Int AIDS Soc. 2022 Jan;25(1):e25852. doi: 10.1002/jia2.25852.
PubMed 35041776Helova A, Onono M, Abuogi LL, Hampanda K, Owuor K, Odwar T, Krishna S, Odhiambo G, Odeny T, Turan JM. Experiences, perceptions and potential impact of community-based mentor mothers supporting pregnant and postpartum women with HIV in Kenya: a mixed-methods study. J Int AIDS Soc. 2021 Nov;24(11):e25843. doi: 10.1002/jia2.25843.
PubMed 34797955Onono M, Odwar T, Wahome S, Helova A, Bukusi EA, Hampanda K, Turan J, Abuogi L. Behavioral Interventions can Mitigate Adverse Pregnancy Outcomes Among Women Conceiving on ART and Those Initiated on ART During Pregnancy: Findings From the MOTIVATE Trial in Southwestern Kenya. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):46-55. doi: 10.1097/QAI.0000000000002521.
PubMed 33306563Palmer 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 32813276Wanga I, Helova A, Abuogi LL, Bukusi EA, Nalwa W, Akama E, Odeny TA, Turan JM, Onono M. Acceptability of community-based mentor mothers to support HIV-positive pregnant women on antiretroviral treatment in western Kenya: a qualitative study. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):288. doi: 10.1186/s12884-019-2419-z.
PubMed 31409297Odeny TA, Onono M, Owuor K, Helova A, Wanga I, Bukusi EA, Turan JM, Abuogi LL. Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial. Trials. 2018 Jan 29;19(1):77. doi: 10.1186/s13063-018-2464-3.
PubMed 29378622
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
- ClinicalTrials.gov ID
- NCT02491177
- Acronym / sponsor ID
- MOTIVATE! / 14-0331
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV Transmission, Prevention of Mother to Child Transmission, Linkage to care, Retention in care, Community Mentor Mothers, Mobile phone text messaging, Antiretroviral therapy adherence, Infant Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,338 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.
Detailed description
In order to eliminate new pediatric HIV infections, save maternal lives, and simplify antiretroviral therapy (ART) implementation in settings with generalized HIV epidemics, current World Health Organization (WHO) guidance recommends lifelong triple ART for all pregnant and breastfeeding women (Option B+). However, despite the promise of Option B+ to remove logistical barriers and to promote maternal health through life-long ART, this strategy brings challenges. Key amongst these challenges are adherence to ART and continuous retention in HIV care, especially for women who do not require ART for their own health. Barriers to adherence and retention in care for prevention of mother-to-child transmission (PMTCT) have been identified at the individual, interpersonal, community, and health facility levels; yet specific barriers in the context of Option B+ are not well understood. The investigators' study will be conducted at 20 health facilities and associated communities in Nyanza Province, Kenya where Mother to Child Transmission (MTCT) rates prior to Option B+ roll-out remained near 10%, despite the wide availability of PMTCT services. As Option B+ is scaled up in Kenya, it is essential to identify effective methods to ensure long-term adherence and retention in care for mother-baby pairs, throughout pregnancy, breastfeeding, and beyond. Building on the investigating team's prior research experience in this setting, the investigators propose to gain understanding of and address potential barriers at the individual, community, and health facility levels through formative research with HIV-positive pregnant and postpartum women, their male partners, and health care providers. This information will be used to refine two proposed interventions that are highly likely to maximize ART adherence and retention in care among HIV-infected pregnant women and HIV-exposed infants. These interventions will be rigorously tested in rural Kenya, using a cluster randomized 2x2 factorial design. The evidence-based interventions to be tested will include 1) community Mentor Mothers (cMM) who will provide support for ART adherence and retention in care for HIV-positive women in the community and 2) individually tailored, theory based mobile phone text messages to help retain women and infants in HIV care. The investigators' overall goal is to determine which intervention (or combination of interventions) maximizes ART adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes. The investigators' primary outcomes will include ART adherence at 12 months postpartum and retention in care, measured by a documented HIV care visit within 90 days prior to 12 months postpartum. Secondary outcomes will include MTCT at 6 weeks, 12 months and 18 months; as well as maternal viral loads and CD4 counts. Results from this study will inform the scale-up of Option B+ in Kenya by identifying effective interventions and combinations of interventions that can reduce barriers and increase facilitators of optimal ART adherence and retention in care with the aims of reaching the elimination of mother to child transmission of HIV and significantly improving maternal health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cMM and Text Messaging | Other | Behavioral: cMM, Behavioral: Text MessagingParticipants randomized to this arm will receive both the community mentor mother and mobile phone text messaging intervention. The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language. |
| cMM Only | Other | Behavioral: cMMParticipants randomized to this arm will receive the community mentor mother intervention only.The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits. |
| Text Messaging Only | Other | Behavioral: Text MessagingParticipants randomized to this arm will receive the mobile phone text messaging intervention only. The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language. |
| Neither cMM nor Text Messaging | No intervention | –Participants randomized to this arm will receive standard of care with no interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older,
- HIV-infected pregnant women and their HIV-exposed infants pairs,
- attends the antenatal care (ANC) clinic at one of the study sites.
Key exclusion criteria (3 listed)
- Less than 18 years of age,
- HIV-infected women not currently pregnant,
- not HIV-infected at the time of the first ANC visit.
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 |
|---|---|---|
| cMMHome visits from community mentor mothers | Behavioural | cMM Only, cMM and Text Messaging |
| Text MessagingText messages received on mobile phone | Behavioural | Text Messaging Only, cMM and Text Messaging |
Primary outcome
Self-reported adherence on antiretroviral therapy
Time frame: 12 months post-partum
Self-report
Adherence on antiretroviral therapy
Time frame: 12 months post-partum
Viral load<100 copies/ml based on medical records
Adherence on antiretroviral therapy (infant)
Time frame: 12 months post-partum
Use of ARVs for the infant
Retention in care
Time frame: 12 months post-partum
Proportion of women who have an HIV care visit within 90 days at 12 months after the birth
Adherence on antiretroviral therapy (dried blood spots)
Time frame: 12 months post-partum
Viral load<100 copies/ml based on dried blood spots
13 secondary outcomes
Maternal CD4 count change
Time frame: 6 months after baseline
Maternal viral load count change
Time frame: 6 months after baseline
Infant retention in care (feeding method)
Time frame: 12 and 18 months
Infant retention in care
Time frame: 12 and 18 months
Infant retention in care (survival status)
Time frame: 12 and 18 months
Uptake of intervention services (Number/types of text messages sent)
Time frame: 3 years
Uptake of intervention services (receipt of text messages)
Time frame: 3 years
Uptake of intervention services (home visits)
Time frame: 3 years
Uptake of intervention services (support groups attended)
Time frame: 3 years
Mother-to-Child-Transmission
Time frame: 6 weeks, 9 months and 18 months
Infant testing
Time frame: 6 weeks, 9 months and 18 months
Infant enrollment in care
Time frame: 6 weeks
Male partner involvement
Time frame: 12 months post-partum
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 26 Apr 2021.
- Derived from this study: PubMed 35041776Abuogi LL, Onono M, Odeny TA, Owuor K, Helova A, Hampanda K, Odwar T, Onyango D, McClure LA, Bukusi EA, Turan JM. Effects of behavioural interventions on postpartum retention and adherence among women with HIV on lifelong ART: the results of a cluster randomized trial in Kenya (the MOTIVATE trial). J Int AIDS Soc. 2022 Jan;25(1):e25852. doi: 10.1002/jia2.25852.
- Derived from this study: PubMed 34797955Helova A, Onono M, Abuogi LL, Hampanda K, Owuor K, Odwar T, Krishna S, Odhiambo G, Odeny T, Turan JM. Experiences, perceptions and potential impact of community-based mentor mothers supporting pregnant and postpartum women with HIV in Kenya: a mixed-methods study. J Int AIDS Soc. 2021 Nov;24(11):e25843. doi: 10.1002/jia2.25843.
- Derived from this study: PubMed 33306563Onono M, Odwar T, Wahome S, Helova A, Bukusi EA, Hampanda K, Turan J, Abuogi L. Behavioral Interventions can Mitigate Adverse Pregnancy Outcomes Among Women Conceiving on ART and Those Initiated on ART During Pregnancy: Findings From the MOTIVATE Trial in Southwestern Kenya. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):46-55. doi: 10.1097/QAI.0000000000002521.
- 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.
- Derived from this study: PubMed 31409297Wanga I, Helova A, Abuogi LL, Bukusi EA, Nalwa W, Akama E, Odeny TA, Turan JM, Onono M. Acceptability of community-based mentor mothers to support HIV-positive pregnant women on antiretroviral treatment in western Kenya: a qualitative study. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):288. doi: 10.1186/s12884-019-2419-z.
- Derived from this study: PubMed 29378622Odeny TA, Onono M, Owuor K, Helova A, Wanga I, Bukusi EA, Turan JM, Abuogi LL. Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial. Trials. 2018 Jan 29;19(1):77. doi: 10.1186/s13063-018-2464-3.
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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.
Lisa Abuogi, MD, MSc principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cMM and Text Messaging in people with Human Immunodeficiency Virus, run by University of Colorado, Denver at 1 site in Kenya.
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 3 inclusion and 3 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 26 Apr 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 Kenya. 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?
Self-reported adherence on antiretroviral therapy (time frame: 12 months post-partum). The study lists 5 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 NCT02491177, which also lists 6 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 26 Apr 2021.