HIV InfectionEPAZNCT02216734
Effects of Facility-based Mother Support Groups on Prevention of mother-to Child Transmission Outcomes in Zimbabwe
A study testing Mother support groups for HIV+ mothers in people with HIV Infection, run by Family AIDS Caring Trust at 2 sites in Zimbabwe.
Trial summary
The investigators hypothesize that a strategy of establishing facility-based mother support groups (MSGs) for HIV-positive mothers will result in increased retention rates of HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery compared to clinics that lack MSGs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infection
- What is being tested?
- Mother support groups for HIV+ mothers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesZimbabwe
- Study dates
- Jul 2014to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant mothers
- with documented HIV-1 infection attending an antenatal clinic for the current pregnancy
- Aged 18 years of age or greater
- Attending the clinic with no known intention at the time of enrolment to permanently migrate outside the catchment area of the clinic for the duration of the study follow-up period
- Estimated gestational age of 34 weeks or less at time of enrolment
- Willing to have her infant, when born, participate in the study.
- Able and willing to give informed consent to participate
Who cannot join
- Pregnant mothers with no documented HIV infection
- Under 18 years of age
- Not able or willing to give informed consent to participate
- Estimated gestational age of over 34 weeks when considered for possible enrolment
- Not residing in catchment area of clinic
- Planning to relocate out of the catchment area of the clinic for the duration of study follow-up period or longer
- Any condition that in the opinion of the investigators would interfere with adherence to study requirements. Such conditions include mental illness or active drug or alcohol use or dependence.
- Unwilling for her infant, when born, to participate in the infant component of the study
Trial locations and contacts
2 sites in 1 country.
Zimbabwe2 sites, 2 recruiting
- Recruiting
Family AIDS Caring Trust
Mutare, Manicaland Province
Vhumani Magezi, +2632061648, vhumani@hotmail.com
- Enrolling by invitation
Family AIDS Caring Trust
Mutare, Manicaland Province
About this study
Official title: Effects of Mother Support Groups on Prevention of Mother-To-Child Transmission (PMTCT) Outcomes in Mutare & Makoni Districts, Zimbabwe: A Cluster Randomized Controlled Trial
The investigators hypothesize that a strategy of establishing facility-based mother support groups (MSGs) for HIV-positive mothers will result in increased retention rates of HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery compared to clinics that lack MSGs. The study will be conducted in health facilities in rural Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster controlled study design will be used in 30 rural clinics randomly assigned to either arm to compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm 2 consists of standard of care together with facility-based MSGs.
Read the detailed description
PRIMARY OBJECTIVE To test whether MSGs lead to increased retention of HIV-exposed infants in PMTCT programmes
SECONDARY OBJECTIVES
- To assess whether MSGs lead to increased retention of mothers in postnatal HIV follow-up care
- To assess whether male participation in PMTCT activities is increased at clinics with MSGs
- To assess whether selected maternal and infant health indicators are improved in HIV-positive mothers and their exposed infants at facilities with MSGs, viz. (1) Antenatal attendance; (2) Delivery in facilities; (3) Infant immunisation uptake; (4) Infant feeding methods and nutrition status; (5) Infant nevirapine prophylaxis; (6) Infant co-trimoxazole prophylaxis; (7) Infant HIV testing; and (8) Family planning uptake
MOTHER SUPPORT GROUP INTERVENTION MSGs were designed following formative research. A non-governmental organisation established MSGs by recruiting HIV+ mothers and volunteer coordinators (MSGCs) prior to commencing enrolment. MSGCs were HIV-positive mothers who were trained in MSG establishment and maintenance, retention activities and data collection. MSGs meet each two weeks with the MSGC or health worker facilitating an information session using a curriculum of eight PMTCT-related topics. MSGCs send standard message reminders to members, contact non-attending members by phone and inform health workers (HWs) to assist retention. HWs conduct retention actions of non-attending patients in PMTCT programmes.
SAMPLE SIZE AND RANDOMISATION We excluded from the study low-volume facilities that recorded booking fewer than 10 HIV-positive antenatal mothers per annum. We randomly selected facilities in the two study districts to either of the study arms. Based on estimated infant retention rates for control and intervention arms, we calculated the minimum sample size of 10 HIV-positive mothers to be enrolled at each health facility.
DATA COLLECTION, ANALYSIS AND QUALITY ASSURANCE The study utilizes the existing health information system (e.g. antenatal care (ANC) Register, Exposed Infant Follow-Up Register, Anti-retroviral treatment (ART) Register), supplemented by EPAZ study-related data collection and patient tracking systems. Study staff will work with clinic- and district-level staff to improve and collect routine and study-specific data. Data will be entered, coded, cleaned and locked before analyses are made. Data will be analysed on an intention-to-treat basis. A mobile team of well-trained quality assurance and control study staff will be deployed throughout the data collection period to ensure quality of the intervention and of data generated and collected at each study site. A pre-specified proportion of patient visit records will be reviewed from each site.
- Conditions
- HIV Infection
- Being tested
- Mother support groups for HIV+ mothers
- Keywords
- HIV/AIDS, Prevention of mother-to-child transmission, Mother support groups, Retention-in-care, Male participation, Anti-retroviral treatment, Infants
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother support groups for HIV+ mothersBehavioural
Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;
| Study group | Role | What they receive |
|---|---|---|
| Mother support groups for HIV+ mothers | Experimental | Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU; Receives: Behavioral: Mother support groups for HIV+ mothers |
| Standard of Care Arm | No intervention | Standard of Care: Nurses may identify HIV+ mothers lost to follow-up (LTFU); village health workers (VHWs) may conduct home visits to reduce LTFU of HIV+ mothers. LTFU activities are not standardised throughout all Ministry of Health and Child Care facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year retention rates of HIV-exposed infants in post-natal follow-up
Measured: 12 months postnatal
Secondary outcomes (1)
a. Retention rates of HIV-infected mothers
Measured: 12 months postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Family AIDS Caring Trust
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Canadian International Development Agency
- Responsible party
- Sponsor
- Investigators
- Geoff Foster, MB BS MRCP, Principal investigator, Ministry of Health and Child Welfare, Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216734
- Sponsor's protocol ID
- RPC526
- Acronym
- EPAZ
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.
PubMed 28498193Foster G, Orne-Gliemann J, Font H, Kangwende A, Magezi V, Sengai T, Rusakaniko S, Shumba B, Zambezi P, Maphosa T. Impact of Facility-Based Mother Support Groups on Retention in Care and PMTCT Outcomes in Rural Zimbabwe: The EPAZ Cluster-Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S207-S215. doi: 10.1097/QAI.0000000000001360.
PubMed 28498191Foster G, Kangwende A, Magezi V, Maphosa T, Mashapa R, Mukora-Mutseyekwa F, Mushavi A, Rusakaniko S, Shumba B, Zambezi P. Cluster randomized trial on the effect of mother support groups on retention-in-care and PMTCT outcomes in Zimbabwe: study design, challenges, and national relevance. J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S145-9. doi: 10.1097/QAI.0000000000000325.
PubMed 25310121
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mother Support Groups on Prevention of Mother-To-Child Transmission (PMTCT) Outcomes in Mutare & Makoni Districts, Zimbabwe: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02216734
- Acronym / sponsor ID
- EPAZ / RPC526
- Conditions
- HIV Infection
- Keywords
- HIV/AIDS, Prevention of mother-to-child transmission, Mother support groups, Retention-in-care, Male participation, Anti-retroviral treatment, Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Family AIDS Caring TrustUniversity, hospital or other
- Collaborators
- World Health Organization, Canadian International Development Agency
- Study start
- Jul 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Aug 2014 (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 investigators hypothesize that a strategy of establishing facility-based mother support groups (MSGs) for HIV-positive mothers will result in increased retention rates of HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery compared to clinics that lack MSGs. The study will be conducted in health facilities in rural Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster controlled study design will be used in 30 rural clinics randomly assigned to either arm to compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm 2 consists of standard of care together with facility-based MSGs.
Detailed description
PRIMARY OBJECTIVE To test whether MSGs lead to increased retention of HIV-exposed infants in PMTCT programmes
SECONDARY OBJECTIVES
- To assess whether MSGs lead to increased retention of mothers in postnatal HIV follow-up care
- To assess whether male participation in PMTCT activities is increased at clinics with MSGs
- To assess whether selected maternal and infant health indicators are improved in HIV-positive mothers and their exposed infants at facilities with MSGs, viz. (1) Antenatal attendance; (2) Delivery in facilities; (3) Infant immunisation uptake; (4) Infant feeding methods and nutrition status; (5) Infant nevirapine prophylaxis; (6) Infant co-trimoxazole prophylaxis; (7) Infant HIV testing; and (8) Family planning uptake
MOTHER SUPPORT GROUP INTERVENTION MSGs were designed following formative research. A non-governmental organisation established MSGs by recruiting HIV+ mothers and volunteer coordinators (MSGCs) prior to commencing enrolment. MSGCs were HIV-positive mothers who were trained in MSG establishment and maintenance, retention activities and data collection. MSGs meet each two weeks with the MSGC or health worker facilitating an information session using a curriculum of eight PMTCT-related topics. MSGCs send standard message reminders to members, contact non-attending members by phone and inform health workers (HWs) to assist retention. HWs conduct retention actions of non-attending patients in PMTCT programmes.
SAMPLE SIZE AND RANDOMISATION We excluded from the study low-volume facilities that recorded booking fewer than 10 HIV-positive antenatal mothers per annum. We randomly selected facilities in the two study districts to either of the study arms. Based on estimated infant retention rates for control and intervention arms, we calculated the minimum sample size of 10 HIV-positive mothers to be enrolled at each health facility.
DATA COLLECTION, ANALYSIS AND QUALITY ASSURANCE The study utilizes the existing health information system (e.g. antenatal care (ANC) Register, Exposed Infant Follow-Up Register, Anti-retroviral treatment (ART) Register), supplemented by EPAZ study-related data collection and patient tracking systems. Study staff will work with clinic- and district-level staff to improve and collect routine and study-specific data. Data will be entered, coded, cleaned and locked before analyses are made. Data will be analysed on an intention-to-treat basis. A mobile team of well-trained quality assurance and control study staff will be deployed throughout the data collection period to ensure quality of the intervention and of data generated and collected at each study site. A pre-specified proportion of patient visit records will be reviewed from each site.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mother support groups for HIV+ mothers | Experimental | Behavioral: Mother support groups for HIV+ mothersFacility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU; |
| Standard of Care Arm | No intervention | –Standard of Care: Nurses may identify HIV+ mothers lost to follow-up (LTFU); village health workers (VHWs) may conduct home visits to reduce LTFU of HIV+ mothers. LTFU activities are not standardised throughout all Ministry of Health and Child Care facilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant mothers
- with documented HIV-1 infection attending an antenatal clinic for the current pregnancy
- Aged 18 years of age or greater
- Attending the clinic with no known intention at the time of enrolment to permanently migrate outside the catchment area of the clinic for the duration of the study follow-up period
- Estimated gestational age of 34 weeks or less at time of enrolment
Key exclusion criteria (8 listed)
- Pregnant mothers with no documented HIV infection
- Under 18 years of age
- Not able or willing to give informed consent to participate
- Estimated gestational age of over 34 weeks when considered for possible enrolment
- Not residing in catchment area of clinic
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 |
|---|---|---|
| Mother support groups for HIV+ mothersFacility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU; | Behavioural | Mother support groups for HIV+ mothers |
Primary outcome
One-year retention rates of HIV-exposed infants in post-natal follow-up
Time frame: 12 months postnatal
1 secondary outcome
a. Retention rates of HIV-infected mothers
Time frame: 12 months postnatal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Derived from this study: PubMed 28498193Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.
- Derived from this study: PubMed 28498191Foster G, Orne-Gliemann J, Font H, Kangwende A, Magezi V, Sengai T, Rusakaniko S, Shumba B, Zambezi P, Maphosa T. Impact of Facility-Based Mother Support Groups on Retention in Care and PMTCT Outcomes in Rural Zimbabwe: The EPAZ Cluster-Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S207-S215. doi: 10.1097/QAI.0000000000001360.
- Derived from this study: PubMed 25310121Foster G, Kangwende A, Magezi V, Maphosa T, Mashapa R, Mukora-Mutseyekwa F, Mushavi A, Rusakaniko S, Shumba B, Zambezi P. Cluster randomized trial on the effect of mother support groups on retention-in-care and PMTCT outcomes in Zimbabwe: study design, challenges, and national relevance. J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S145-9. doi: 10.1097/QAI.0000000000000325.
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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.
Geoff Foster, MB BS MRCP principal investigator
Ministry of Health and Child Welfare, Zimbabwe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother support groups for HIV+ mothers in people with HIV Infection, run by Family AIDS Caring Trust at 2 sites in Zimbabwe.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zimbabwe. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geoff Foster, MB BS MRCP (+263772265830, geofffoster53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year retention rates of HIV-exposed infants in post-natal follow-up (time frame: 12 months postnatal). 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 NCT02216734, which also lists 3 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 15 Aug 2014.