HIVPURENCT02005835
Promoting Uptake and Retention of Option B+ in Malawi
A study testing Community based peer support and Facility-based Peer Support in people with HIV, run by Lighthouse Trust at 1 site in Malawi.
Trial summary
The purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Community based peer support and Facility-based Peer Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteMalawi
- Study dates
- Nov 2013to Aug 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV infected women Presenting for Antenatal Care, Labor\&Delivery, or post-partum Infants of Enrolled mothers Husbands/Spouses of Enrolled mothers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Malawi1 site, 1 recruiting
- Recruiting
Ministry of Health Facilities
Lilongwe
Sam Phiri, Ph.D., MSc
Hannock Tweya, MSc.,BSc.
About this study
Official title: Improving Uptake and Retention in PMTCT Services Through Novel Approaches in Family Supported Care and in Community Peer Outreach Support in Malawi
The purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.
Read the detailed description
The Malawi Ministry of Health (MoH) has embarked on a novel and ambitious programme to prevent mother to child transmission of HIV (PMTCT) known as "Option B Plus". This programme takes a public health approach to promote maternal health and eliminate paediatric HIV infections through a "test and treat" model, offering all HIV-infected pregnant and breastfeeding women lifelong ART regardless of CD4 count or clinical stage. The overall goal is to improve ART uptake and retention, and thus outcomes, of HIV-infected pregnant women and their infants in the continuum of ART services.
Although the Option B Plus strategy offers an attractive rapid ART scale-up alternative to the WHO PMTCT recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. Operational challenges throughout the cascade of PMTCT services may affect the uptake and adherence to highly active ART treatment (HAART) by pregnant women, the follow-up of HIV-exposed infants and the long-term retention of this patient population. Several issues identified at the national level are potential threats to the successful implementation and scale up of Option B plus: a) potential suboptimal uptake of HAART by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to HAART and poor follow-up of HIV exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (Schouten et al. 2011).
The aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in PMTCT care in Malawi. Our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.
We will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the Option B+ program. Each of the 21 clinics will be randomized to one of the three adherence and support strategies. Arm 1 is the standard of care arm as outlined by the Ministry of Health, Arm 2 is facility level support by a peer educator and Arm 3 is community level support by a peer educator.
- Conditions
- HIV
- Being tested
- Community based peer support, Facility-based Peer Support
- Keywords
- HIV, Option B+, Prevention of Mother to Child Transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community based peer supportOther
Community-based Support from Peer Mothers (Expert mothers):
Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment
Facility-based Peer SupportOther
Facility-based Peer Support to provide the following at the clinic
Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment
| Study group | Role | What they receive |
|---|---|---|
| Facility-based Peer Support | Other | Facility-based Peer Support to provide the following at the clinic
* Routine standard clinical care based on the MoH guidelines
* Mentor mothers provide education and psychosocial support at facility
* Weekly support groups provided in clinic
* Phone call, SMS, or home visit for each missed appointment Receives: Other: Facility-based Peer Support |
| Community-based Peer Support | Other | Community-based Support from Peer Mothers (Expert mothers):
* Routine standard clinical care based on the MoH guidelines
* Mentor mothers provide education and psychosocial support in community prior to each visit
* Monthly support groups in community
* Home visits for each missed appointment Receives: Other: Community based peer support |
| Standard of Care | No intervention | The Standard of care as outlined in the Malawi HIV integrated Care Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Care
The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.
Measured: 12 months post ART initiation
Secondary outcomes (8)
Retention at 24 months
The proportion of Women alive and retained on ART at 24 months post ART initiation
Measured: 24 months post ART initiation
Child HIV status
Children tested at 6 weeks, 12 months, and 24 months
Measured: 6 weeks, 12 months, 24 months
HIV free survival
HIV-free infant survival at 6-weeks, 12 months and 24 months
Measured: 6 weeks, 12 months, 24 months
Family retention
Partner/family involvement, including: a) husband/children tested for HIV; b. eligible husbands/children who start ART; c. husband/children engaged in care at 12 months
Measured: 12 months
Maternal Viral Load
Proportion of women with HIVRNA <1000 copies at 6 months and 2 years post initiation
Measured: 6 months and 2 years post ART initiation
Maternal resistance
Of women failing ART, the proportion with HIV drug resistance
Measured: 6 months, 2 years
Infant HIV resistance
Of HIV infected infants, the proportion with HIV drug resistance
Measured: 6 weeks, 12 months, 24 months
Social outcomes
Social outcomes, including impact of task shifting on burden of care in facilities, quality of life for patients and their families, disclosure and shifts in boundaries of professional and lay care for lay health care workers as assessed by mixed methodology.
Measured: 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015 (estimated)
- Study completionAug 2016 (estimated)
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 HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lighthouse Trust
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, AIDS Fonds, Mothers2Mothers, Kamuzu University of Health Sciences, Management Sciences for Health, Dignitas International, University of North Carolina, Chapel Hill, University of Malawi, Ministry of Health, Malawi
- Responsible party
- Principal investigator, Sam Phiri, PhD, MSc, DCM, Lighthouse Trust
- Investigators
- Sam Phiri, PhD, MSc., Principal investigator, Lighthouse Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005835
- Sponsor's protocol ID
- PUREMalawi
- Acronym
- PURE
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van Lettow M, Tweya H, Rosenberg NE, Trapence C, Kayoyo V, Kasende F, Kaunda B, Hosseinipour MC, Eliya M, Cataldo F, Gugsa S, Phiri S; PURE Malawi consortium. Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi. Reprod Health. 2017 Jul 11;14(1):82. doi: 10.1186/s12978-017-0343-0.
PubMed 28693525Cataldo 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 28498193Hosseinipour M, Nelson JAE, Trapence C, Rutstein SE, Kasende F, Kayoyo V, Kaunda-Khangamwa B, Compliment K, Stanley C, Cataldo F, van Lettow M, Rosenberg NE, Tweya H, Gugsa S, Sampathkumar V, Schouten E, Eliya M, Chimbwandira F, Chiwaula L, Kapito-Tembo A, Phiri S; PURE Malawi Consortium. Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2(Suppl 2):S149-S155. doi: 10.1097/QAI.0000000000001368.
PubMed 28498184Phiri S, Tweya H, van Lettow M, Rosenberg NE, Trapence C, Kapito-Tembo A, Kaunda-Khangamwa B, Kasende F, Kayoyo V, Cataldo F, Stanley C, Gugsa S, Sampathkumar V, Schouten E, Chiwaula L, Eliya M, Chimbwandira F, Hosseinipour MC; PURE Malawi Consortium. Impact of Facility- and Community-Based Peer Support Models on Maternal Uptake and Retention in Malawi's Option B+ HIV Prevention of Mother-to-Child Transmission Program: A 3-Arm Cluster Randomized Controlled Trial (PURE Malawi). J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S140-S148. doi: 10.1097/QAI.0000000000001357.
PubMed 28498183Cataldo F, Chiwaula L, Nkhata M, van Lettow M, Kasende F, Rosenberg NE, Tweya H, Sampathkumar V, Hosseinipour M, Schouten E, Kapito-Tembo A, Eliya M, Chimbwandira F, Phiri S; PURE Malawi Consortium. Exploring the Experiences of Women and Health Care Workers in the Context of PMTCT Option B Plus in Malawi. J Acquir Immune Defic Syndr. 2017 Apr 15;74(5):517-522. doi: 10.1097/QAI.0000000000001273.
PubMed 28045712Chiwaula LS, Chirwa GC, Cataldo F, Kapito-Tembo A, Hosseinipour MC, van Lettow M, Tweya H, Kayoyo V, Khangamwa-Kaunda B, Kasende F, Trapence C, Gugsa S, Rosenberg NE, Eliya M, Phiri S; PURE Malawi Consortium. The value of informal care in the context of option B+ in Malawi: a contingent valuation approach. BMC Health Serv Res. 2016 Apr 19;16:136. doi: 10.1186/s12913-016-1381-y.
PubMed 27095249
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Uptake and Retention in PMTCT Services Through Novel Approaches in Family Supported Care and in Community Peer Outreach Support in Malawi
- ClinicalTrials.gov ID
- NCT02005835
- Acronym / sponsor ID
- PURE / PUREMalawi
- Conditions
- HIV
- Keywords
- HIV, Option B+, Prevention of Mother to Child Transmission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Lighthouse TrustUniversity, hospital or other
- Collaborators
- World Health Organization, AIDS Fonds, Mothers2Mothers, Kamuzu University of Health Sciences, Management Sciences for Health, Dignitas International, University of North Carolina, Chapel Hill, University of Malawi, Ministry of Health, Malawi
- Study start
- Nov 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Dec 2013 (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 determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.
Detailed description
The Malawi Ministry of Health (MoH) has embarked on a novel and ambitious programme to prevent mother to child transmission of HIV (PMTCT) known as "Option B Plus". This programme takes a public health approach to promote maternal health and eliminate paediatric HIV infections through a "test and treat" model, offering all HIV-infected pregnant and breastfeeding women lifelong ART regardless of CD4 count or clinical stage. The overall goal is to improve ART uptake and retention, and thus outcomes, of HIV-infected pregnant women and their infants in the continuum of ART services.
Although the Option B Plus strategy offers an attractive rapid ART scale-up alternative to the WHO PMTCT recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. Operational challenges throughout the cascade of PMTCT services may affect the uptake and adherence to highly active ART treatment (HAART) by pregnant women, the follow-up of HIV-exposed infants and the long-term retention of this patient population. Several issues identified at the national level are potential threats to the successful implementation and scale up of Option B plus: a) potential suboptimal uptake of HAART by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to HAART and poor follow-up of HIV exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (Schouten et al. 2011).
The aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in PMTCT care in Malawi. Our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.
We will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the Option B+ program. Each of the 21 clinics will be randomized to one of the three adherence and support strategies. Arm 1 is the standard of care arm as outlined by the Ministry of Health, Arm 2 is facility level support by a peer educator and Arm 3 is community level support by a peer educator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facility-based Peer Support | Other | Other: Facility-based Peer SupportFacility-based Peer Support to provide the following at the clinic * Routine standard clinical care based on the MoH guidelines * Mentor mothers provide education and psychosocial support at facility * Weekly support groups provided in clinic * Phone call, SMS, or home visit for each missed appointment |
| Community-based Peer Support | Other | Other: Community based peer supportCommunity-based Support from Peer Mothers (Expert mothers): * Routine standard clinical care based on the MoH guidelines * Mentor mothers provide education and psychosocial support in community prior to each visit * Monthly support groups in community * Home visits for each missed appointment |
| Standard of Care | No intervention | –The Standard of care as outlined in the Malawi HIV integrated Care Guidelines |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HIV infected women Presenting for Antenatal Care, Labor\&Delivery, or post-partum Infants of Enrolled mothers Husbands/Spouses of Enrolled mothers
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community based peer supportCommunity-based Support from Peer Mothers (Expert mothers): Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment | Other | Community-based Peer Support |
| Facility-based Peer SupportFacility-based Peer Support to provide the following at the clinic Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment | Other | Facility-based Peer Support |
Primary outcome
Retention in Care
Time frame: 12 months post ART initiation
The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.
8 secondary outcomes
Retention at 24 months
Time frame: 24 months post ART initiation
Child HIV status
Time frame: 6 weeks, 12 months, 24 months
HIV free survival
Time frame: 6 weeks, 12 months, 24 months
Family retention
Time frame: 12 months
Maternal Viral Load
Time frame: 6 months and 2 years post ART initiation
Maternal resistance
Time frame: 6 months, 2 years
Infant HIV resistance
Time frame: 6 weeks, 12 months, 24 months
Social outcomes
Time frame: 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Derived from this study: PubMed 28693525van Lettow M, Tweya H, Rosenberg NE, Trapence C, Kayoyo V, Kasende F, Kaunda B, Hosseinipour MC, Eliya M, Cataldo F, Gugsa S, Phiri S; PURE Malawi consortium. Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi. Reprod Health. 2017 Jul 11;14(1):82. doi: 10.1186/s12978-017-0343-0.
- 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 28498184Hosseinipour M, Nelson JAE, Trapence C, Rutstein SE, Kasende F, Kayoyo V, Kaunda-Khangamwa B, Compliment K, Stanley C, Cataldo F, van Lettow M, Rosenberg NE, Tweya H, Gugsa S, Sampathkumar V, Schouten E, Eliya M, Chimbwandira F, Chiwaula L, Kapito-Tembo A, Phiri S; PURE Malawi Consortium. Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2(Suppl 2):S149-S155. doi: 10.1097/QAI.0000000000001368.
- Derived from this study: PubMed 28498183Phiri S, Tweya H, van Lettow M, Rosenberg NE, Trapence C, Kapito-Tembo A, Kaunda-Khangamwa B, Kasende F, Kayoyo V, Cataldo F, Stanley C, Gugsa S, Sampathkumar V, Schouten E, Chiwaula L, Eliya M, Chimbwandira F, Hosseinipour MC; PURE Malawi Consortium. Impact of Facility- and Community-Based Peer Support Models on Maternal Uptake and Retention in Malawi's Option B+ HIV Prevention of Mother-to-Child Transmission Program: A 3-Arm Cluster Randomized Controlled Trial (PURE Malawi). J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S140-S148. doi: 10.1097/QAI.0000000000001357.
- Derived from this study: PubMed 28045712Cataldo F, Chiwaula L, Nkhata M, van Lettow M, Kasende F, Rosenberg NE, Tweya H, Sampathkumar V, Hosseinipour M, Schouten E, Kapito-Tembo A, Eliya M, Chimbwandira F, Phiri S; PURE Malawi Consortium. Exploring the Experiences of Women and Health Care Workers in the Context of PMTCT Option B Plus in Malawi. J Acquir Immune Defic Syndr. 2017 Apr 15;74(5):517-522. doi: 10.1097/QAI.0000000000001273.
- Derived from this study: PubMed 27095249Chiwaula LS, Chirwa GC, Cataldo F, Kapito-Tembo A, Hosseinipour MC, van Lettow M, Tweya H, Kayoyo V, Khangamwa-Kaunda B, Kasende F, Trapence C, Gugsa S, Rosenberg NE, Eliya M, Phiri S; PURE Malawi Consortium. The value of informal care in the context of option B+ in Malawi: a contingent valuation approach. BMC Health Serv Res. 2016 Apr 19;16:136. doi: 10.1186/s12913-016-1381-y.
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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.
Sam Phiri, PhD, MSc. principal investigator
Lighthouse Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community based peer support and Facility-based Peer Support in people with HIV, run by Lighthouse Trust at 1 site in Malawi.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 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 Malawi. 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 Clement Trapence, MSc. (265 1 758897, c_Trapence@lighthouse.org.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Care (time frame: 12 months post ART initiation). 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 NCT02005835, 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 9 Dec 2013.