Human Immunodeficiency VirusPhase 2NCT00972699
Mentor Mothers: A Sustainable Family Intervention in South African Townships
A Phase 2 study testing Peer support and mentoring in people with Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome, run by University of California, Los Angeles at 1 site in South Africa.
Trial summary
The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the intervention will enhance the adjustment of the children of MLH by improving the health and mental health of MLH which benefits their… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome, Tuberculosis
- What is being tested?
- Peer support and mentoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2008to Dec 2011
- Phase
- Phase 2
- 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
- 18 years or older, pregnant, and HIV+
- Enrolled in the PMTCT program at the study site clinic
- Receiving medical care from study site clinic
- Residing in study area for duration of study
- No psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
- Ability to give informed consent as judged by an interviewer
Who cannot join
- Less than 18 years, or not pregnant, or not HIV+
- Not enrolled in the PMTCT program at the study site clinic
- Not receiving medical care from study site clinic
- Not residing in study area for duration of study
- Psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
- Clinical provider (nurse or physician) believes it is not in the best interest of the MLH
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
South Africa1 site
HSRC Sweetwaters Site
Pietermaritzburg, KwaZulu-Natal, 3201
About this study
The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the intervention will enhance the adjustment of the children of MLH by improving the health and mental health of MLH which benefits their children, as well as the MLH.
Read the detailed description
South Africa's HIV/AIDS epidemic, one of the worst in the world, has shown little evidence of decline and is indicative of the urgent need to focus on both preventative and treatment intervention efforts (UNAIDS, 2006). In South Africa, close to one in three women who attend public antenatal clinics are living with HIV (UNAIDS, 2006). In KwaZulu-Natal (KZN) - one of the worst affected provinces - as many as 40% to 60% of pregnant women attending antenatal services are living with HIV (Rochat et al., 2006; Kharsany et al., 2004).
HIV infection in pregnant women raises a number of issues that are not faced by HIV-infected men or non pregnant women (Ojikutu \& Stone, 2005) and has particular implications for the successful prevention of mother-to-child transmission (Raisler \& Cohn, 2005). Most women learn their HIV status for the first time during antenatal testing, which can be distressing and may introduce or further compound psychological, social and health risks in the antenatal and post natal period (Firn \& Norman, 1995; Patel V, Rahman A, Jacob KS, \& Hughes M, 2004; Patel, DeSouza, \& Rodrigues, 2003; Rochat et al., 2006; Shisana et al., 2005; Stein et al., 2005). Research on the uptake of treatment for HIV indicates that poor mental health and a lack of social support are associated with lowered uptake of HAART (Cook et al., 2006), lowered adherence to anti-retroviral medication (Ammassari, Trotta, Murri, \& et al., 2002; DiMatteo, Lepper, \& Croghan, 2000; Ickovics et al., 2001; Starace et al., 2002)and increased disease progression (Ickovics et al., 2001).
Fortunately, HIV testing and access to antiretroviral drugs (ARV) to prevent mother-to-child transmission (PMTCT) from HIV positive pregnant women to their babies are currently being scaled up in South Africa (Civil Society HIV and AIDS Congress, 2005; Department of Health, 2005). While the potential exists to cut transmission to babies from mothers living with HIV(MLH), maternal HIV disease has been demonstrated to have negative consequences on maternal mental health and social support and children's emotional, social and developmental outcomes and adjustment - both as a result of chronic HIV illness and as a result of the psychological and social burden of HIV on care giving (Stein et al., 2005; Krebs, Stein, \& Rochat, 2005; Stein et al., 2005; Sherr, 2005; Dunn, 2005; Hough, Brumitt, Templin, Saltz, \& Mood, 2003).
While PMTCT programs provide the opportunity for women to prevent transmission through medical and feeding interventions, the needs of mothers living with HIV extend well beyond this. The psychosocial challenges facing mothers living with HIV are substantial and, if children are to have positive outcomes, it is necessary to provide mothers living with HIV with the support, skills and knowledge to protect and promote their own health and well-being, that of their babies, and, hopefully, their partners (Rochat et al., 2006; Stein et al., 2005; 2006).
The goal of this randomized trial then is to test an intervention to improve the health and well-being of HIV positive mothers and their babies during pregnancy and the early postpartum period through the implementation of a clinic-based mentor mothers' peer support program(also referred to as Project Masihambisane) and dissemination of health information.
- Being tested
- Peer support and mentoring
- Keywords
- Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome, Tuberculosis, Women, Pregnancy, Vertical Transmission of Human Immunodeficiency Virus, South Africa, Low Birth Weight
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support and mentoringBehavioural
Also called Masihambisane
The intervention will be delivered in 4 non consecutive visits during pregnancy and 4 visits post-partum. The sessions will be delivered to mothers living with HIV on the days of their health care appointments either individually or in groups that can accommodate up to 30 mothers living with HIV. The intervention will focus on enhancing the mother-baby relationship through increasing the health of the mother and baby, maintaining the mother's mental health, and reducing HIV transmission.
| Study group | Role | What they receive |
|---|---|---|
| Mentor Mothers Intervention | Experimental | In the intervention arm, participants will receive the Department of Health-delivered Prevention of Mother to Child Transmission (PMTCT) program plus the Project Masihambisane mentor mothers support program. HIV positive mentor mothers, who have been through the PMTCT program, will be recruited and trained to deliver the intervention to pregnant mothers living with HIV. Receives: Behavioral: Peer support and mentoring |
| Control | No intervention | Mothers living with HIV in the standard of care control clinics will receive the Department of Health-delivered PMTCT program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baby's health status
Measured: 6 days after birth; 6 months after birth; 12 months after birth
Secondary outcomes (1)
Maternal adherence: baby's and mother's health.
Measured: 6 days after birth; 6 months after birth; 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 California, Los AngelesThe 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Human Sciences Research Council
- Responsible party
- Principal investigator, Mary Jane Rotheram-Borus, University of California, Los Angeles
- Investigators
- Mary Jane Rotheram-Borus, Ph.D., Principal investigator, UCLA Semel Institute, Center for Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972699
- Sponsor's protocol ID
- R01MH077553
- Other IDs
- R01MH077553, DAHBR 9A-ASPA
- Status last verified
- May 2013
- First submitted
- 4 Sep 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christodoulou J, Rotheram-Borus MJ, Bradley AK, Tomlinson M. Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa. J Am Acad Child Adolesc Psychiatry. 2019 Dec;58(12):1165-1174. doi: 10.1016/j.jaac.2019.03.016. Epub 2019 Mar 26.
PubMed 30926571Rotheram-Borus MJ, Tomlinson M, Roux IL, Stein JA. Alcohol Use, Partner Violence, and Depression: A Cluster Randomized Controlled Trial Among Urban South African Mothers Over 3 Years. Am J Prev Med. 2015 Nov;49(5):715-725. doi: 10.1016/j.amepre.2015.05.004. Epub 2015 Jul 29.
PubMed 26231855Richter L, Rotheram-Borus MJ, Van Heerden A, Stein A, Tomlinson M, Harwood JM, Rochat T, Van Rooyen H, Comulada WS, Tang Z. Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial. AIDS Behav. 2014 Apr;18(4):706-15. doi: 10.1007/s10461-014-0694-2.
PubMed 24469222Rotheram-Borus MJ, Richter LM, van Heerden A, van Rooyen H, Tomlinson M, Harwood JM, Comulada WS, Stein A. A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants. PLoS One. 2014 Jan 22;9(1):e84867. doi: 10.1371/journal.pone.0084867. eCollection 2014.
PubMed 24465444van Heerden A, Norris S, Tollman S, Richter L, Rotheram-Borus MJ. Collecting maternal health information from HIV-positive pregnant women using mobile phone-assisted face-to-face interviews in Southern Africa. J Med Internet Res. 2013 Jun 10;15(6):e116. doi: 10.2196/jmir.2207.
PubMed 23748182Rotheram-Borus MJ, le Roux IM, Tomlinson M, Mbewu N, Comulada WS, le Roux K, Stewart J, O'Connor MJ, Hartley M, Desmond K, Greco E, Worthman CM, Idemundia F, Swendeman D. Philani Plus (+): a Mentor Mother community health worker home visiting program to improve maternal and infants' outcomes. Prev Sci. 2011 Dec;12(4):372-88. doi: 10.1007/s11121-011-0238-1.
PubMed 21850488Hartley M, Tomlinson M, Greco E, Comulada WS, Stewart J, le Roux I, Mbewu N, Rotheram-Borus MJ. Depressed mood in pregnancy: prevalence and correlates in two Cape Town peri-urban settlements. Reprod Health. 2011 May 2;8:9. doi: 10.1186/1742-4755-8-9.
PubMed 21535876Rotheram-Borus MJ, Richter L, Van Rooyen H, van Heerden A, Tomlinson M, Stein A, Rochat T, de Kadt J, Mtungwa N, Mkhize L, Ndlovu L, Ntombela L, Comulada WS, Desmond KA, Greco E. Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV. Trials. 2011 Jan 4;12:2. doi: 10.1186/1745-6215-12-2.
PubMed 21205302
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentor Mothers: A Sustainable Family Intervention in South African Townships
- ClinicalTrials.gov ID
- NCT00972699
- Acronym / sponsor ID
- R01MH077553
- Keywords
- Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome, Tuberculosis, Women, Pregnancy, Vertical Transmission of Human Immunodeficiency Virus, South Africa, Low Birth Weight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Human Sciences Research Council
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a mother-to-mother intervention during pregnancy and after delivery with Mothers Living with HIV (MLH)in South Africa. We hypothesize that the intervention will enhance the adjustment of the children of MLH by improving the health and mental health of MLH which benefits their children, as well as the MLH.
Detailed description
South Africa's HIV/AIDS epidemic, one of the worst in the world, has shown little evidence of decline and is indicative of the urgent need to focus on both preventative and treatment intervention efforts (UNAIDS, 2006). In South Africa, close to one in three women who attend public antenatal clinics are living with HIV (UNAIDS, 2006). In KwaZulu-Natal (KZN) - one of the worst affected provinces - as many as 40% to 60% of pregnant women attending antenatal services are living with HIV (Rochat et al., 2006; Kharsany et al., 2004).
HIV infection in pregnant women raises a number of issues that are not faced by HIV-infected men or non pregnant women (Ojikutu \& Stone, 2005) and has particular implications for the successful prevention of mother-to-child transmission (Raisler \& Cohn, 2005). Most women learn their HIV status for the first time during antenatal testing, which can be distressing and may introduce or further compound psychological, social and health risks in the antenatal and post natal period (Firn \& Norman, 1995; Patel V, Rahman A, Jacob KS, \& Hughes M, 2004; Patel, DeSouza, \& Rodrigues, 2003; Rochat et al., 2006; Shisana et al., 2005; Stein et al., 2005). Research on the uptake of treatment for HIV indicates that poor mental health and a lack of social support are associated with lowered uptake of HAART (Cook et al., 2006), lowered adherence to anti-retroviral medication (Ammassari, Trotta, Murri, \& et al., 2002; DiMatteo, Lepper, \& Croghan, 2000; Ickovics et al., 2001; Starace et al., 2002)and increased disease progression (Ickovics et al., 2001).
Fortunately, HIV testing and access to antiretroviral drugs (ARV) to prevent mother-to-child transmission (PMTCT) from HIV positive pregnant women to their babies are currently being scaled up in South Africa (Civil Society HIV and AIDS Congress, 2005; Department of Health, 2005). While the potential exists to cut transmission to babies from mothers living with HIV(MLH), maternal HIV disease has been demonstrated to have negative consequences on maternal mental health and social support and children's emotional, social and developmental outcomes and adjustment - both as a result of chronic HIV illness and as a result of the psychological and social burden of HIV on care giving (Stein et al., 2005; Krebs, Stein, \& Rochat, 2005; Stein et al., 2005; Sherr, 2005; Dunn, 2005; Hough, Brumitt, Templin, Saltz, \& Mood, 2003).
While PMTCT programs provide the opportunity for women to prevent transmission through medical and feeding interventions, the needs of mothers living with HIV extend well beyond this. The psychosocial challenges facing mothers living with HIV are substantial and, if children are to have positive outcomes, it is necessary to provide mothers living with HIV with the support, skills and knowledge to protect and promote their own health and well-being, that of their babies, and, hopefully, their partners (Rochat et al., 2006; Stein et al., 2005; 2006).
The goal of this randomized trial then is to test an intervention to improve the health and well-being of HIV positive mothers and their babies during pregnancy and the early postpartum period through the implementation of a clinic-based mentor mothers' peer support program(also referred to as Project Masihambisane) and dissemination of health information.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentor Mothers Intervention | Experimental | Behavioral: Peer support and mentoringIn the intervention arm, participants will receive the Department of Health-delivered Prevention of Mother to Child Transmission (PMTCT) program plus the Project Masihambisane mentor mothers support program. HIV positive mentor mothers, who have been through the PMTCT program, will be recruited and trained to deliver the intervention to pregnant mothers living with HIV. |
| Control | No intervention | –Mothers living with HIV in the standard of care control clinics will receive the Department of Health-delivered PMTCT program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older, pregnant, and HIV+
- Enrolled in the PMTCT program at the study site clinic
- Receiving medical care from study site clinic
- Residing in study area for duration of study
- No psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
Key exclusion criteria (7 listed)
- Less than 18 years, or not pregnant, or not HIV+
- Not enrolled in the PMTCT program at the study site clinic
- Not receiving medical care from study site clinic
- Not residing in study area for duration of study
- Psychosis, neurological damage, or IQ less than 70, as judged by an interviewer in consultation with a clinical supervisor
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 |
|---|---|---|
| Peer support and mentoringAlso: MasihambisaneThe intervention will be delivered in 4 non consecutive visits during pregnancy and 4 visits post-partum. The sessions will be delivered to mothers living with HIV on the days of their health care appointments either individually or in groups that can accommodate up to 30 mothers living with HIV. The intervention will focus on enhancing the mother-baby relationship through increasing the health of the mother and baby, maintaining the mother's mental health, and reducing HIV transmission. | Behavioural | Mentor Mothers Intervention |
Primary outcome
Baby's health status
Time frame: 6 days after birth; 6 months after birth; 12 months after birth
1 secondary outcome
Maternal adherence: baby's and mother's health.
Time frame: 6 days after birth; 6 months after birth; 12 months after birth
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 3 May 2013.
- Derived from this study: PubMed 30926571Christodoulou J, Rotheram-Borus MJ, Bradley AK, Tomlinson M. Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa. J Am Acad Child Adolesc Psychiatry. 2019 Dec;58(12):1165-1174. doi: 10.1016/j.jaac.2019.03.016. Epub 2019 Mar 26.
- Derived from this study: PubMed 26231855Rotheram-Borus MJ, Tomlinson M, Roux IL, Stein JA. Alcohol Use, Partner Violence, and Depression: A Cluster Randomized Controlled Trial Among Urban South African Mothers Over 3 Years. Am J Prev Med. 2015 Nov;49(5):715-725. doi: 10.1016/j.amepre.2015.05.004. Epub 2015 Jul 29.
- Derived from this study: PubMed 24469222Richter L, Rotheram-Borus MJ, Van Heerden A, Stein A, Tomlinson M, Harwood JM, Rochat T, Van Rooyen H, Comulada WS, Tang Z. Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial. AIDS Behav. 2014 Apr;18(4):706-15. doi: 10.1007/s10461-014-0694-2.
- Derived from this study: PubMed 24465444Rotheram-Borus MJ, Richter LM, van Heerden A, van Rooyen H, Tomlinson M, Harwood JM, Comulada WS, Stein A. A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants. PLoS One. 2014 Jan 22;9(1):e84867. doi: 10.1371/journal.pone.0084867. eCollection 2014.
- Derived from this study: PubMed 23748182van Heerden A, Norris S, Tollman S, Richter L, Rotheram-Borus MJ. Collecting maternal health information from HIV-positive pregnant women using mobile phone-assisted face-to-face interviews in Southern Africa. J Med Internet Res. 2013 Jun 10;15(6):e116. doi: 10.2196/jmir.2207.
- Derived from this study: PubMed 21850488Rotheram-Borus MJ, le Roux IM, Tomlinson M, Mbewu N, Comulada WS, le Roux K, Stewart J, O'Connor MJ, Hartley M, Desmond K, Greco E, Worthman CM, Idemundia F, Swendeman D. Philani Plus (+): a Mentor Mother community health worker home visiting program to improve maternal and infants' outcomes. Prev Sci. 2011 Dec;12(4):372-88. doi: 10.1007/s11121-011-0238-1.
- Derived from this study: PubMed 21535876Hartley M, Tomlinson M, Greco E, Comulada WS, Stewart J, le Roux I, Mbewu N, Rotheram-Borus MJ. Depressed mood in pregnancy: prevalence and correlates in two Cape Town peri-urban settlements. Reprod Health. 2011 May 2;8:9. doi: 10.1186/1742-4755-8-9.
- Derived from this study: PubMed 21205302Rotheram-Borus MJ, Richter L, Van Rooyen H, van Heerden A, Tomlinson M, Stein A, Rochat T, de Kadt J, Mtungwa N, Mkhize L, Ndlovu L, Ntombela L, Comulada WS, Desmond KA, Greco E. Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV. Trials. 2011 Jan 4;12:2. doi: 10.1186/1745-6215-12-2.
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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.
Mary Jane Rotheram-Borus, Ph.D. principal investigator
UCLA Semel Institute, Center for Community Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peer support and mentoring in people with Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome, run by University of California, Los Angeles 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 6 inclusion and 7 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 3 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Baby's health status (time frame: 6 days after birth; 6 months after birth; 12 months after birth). 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 NCT00972699, which also lists 8 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 3 May 2013.