Vertical Transmission of Infectious DiseaseNCT03058484
Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania
A study testing Community Health Worker intervention in people with Vertical Transmission of Infectious Disease and HIV Infections, run by University of California, Berkeley.
Trial summary
The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vertical Transmission of Infectious Disease, HIV Infections
- What is being tested?
- Community Health Worker intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,830 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 30 Mar 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).
Who cannot join
- Did not have sufficient information to link them across registers
About this study
Official title: Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial
The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community.
The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.
- Being tested
- Community Health Worker intervention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker interventionBehavioural
The intervention included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care, i.e. regular clinic services are provided prior to the study. |
| Community Health Worker Intervention | Experimental | This arm is a four-part behavioral intervention that includes: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool. Receives: Behavioral: Community Health Worker intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in HIV care
Binary variable taking the value of 1 if the women has had at least one clinic visit in the postpartum period (60-120 days after birth), and zero otherwise.
Measured: 120 days postpartum
Secondary outcomes (3)
Adherence to ARVs
ART adherence will be measured through a binary variable taking the value of 1 when adherence is at least 95%, and the value of zero otherwise. We measure adherence using the medication possession ratio (MPR), computed as the number of days ARVs are prescribed or dispensed divided by the number of days in the interval. It has been shown to be associated with short-term virologic outcomes.
Measured: Birth to 90 days postpartum
Timing of ART initiation
Defined by gestational week at start of ART, which was computed using standard approaches (i.e., 40 weeks prior to the date of birth or, when available, the expected delivery date based on last menstrual period).
Measured: ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
Initiation of ART
Measured as the number of HIV-infected women in the sample who had any evidence of beginning ART after pregnancy, among women without evidence of treatment prior to pregnancy (women who had initiated ART before the current pregnancy were excluded).
Measured: Through pregnancy and up to 90 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 May 2015
- Primary completion30 Mar 2016
- Study completion30 Mar 2016
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 Vertical Transmission of Infectious DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Amref Health Africa, Ministry of Health and Social Welfare, Tanzania, International Initiative for Impact Evaluation, Organization for Public Health Interventions and Development
- Responsible party
- Principal investigator, Sandra McCoy, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058484
- Sponsor's protocol ID
- TW7.18
- Other IDs
- 552553838b402
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hong SY, Jerger L, Jonas A, Badi A, Cohen S, Nachega JB, Parienti JJ, Tang AM, Wanke C, Terrin N, Pereko D, Blom A, Trotter AB, Jordan MR. Medication possession ratio associated with short-term virologic response in individuals initiating antiretroviral therapy in Namibia. PLoS One. 2013;8(2):e56307. doi: 10.1371/journal.pone.0056307. Epub 2013 Feb 28.
PubMed 23509605Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, Nabiryo C, Ndembi N, Kyomuhangi R, Opio A, Bunnell R, Tappero JW, Mermin J, Coutinho A, Grosskurth H; Jinja trial team. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Lancet. 2009 Dec 19;374(9707):2080-2089. doi: 10.1016/S0140-6736(09)61674-3. Epub 2009 Nov 24.
PubMed 19939445Geldsetzer P, Yapa HM, Vaikath M, Ogbuoji O, Fox MP, Essajee SM, Negussie EK, Barnighausen T. A systematic review of interventions to improve postpartum retention of women in PMTCT and ART care. J Int AIDS Soc. 2016 Apr 25;19(1):20679. doi: 10.7448/IAS.19.1.20679. eCollection 2016.
PubMed 27118443Mwai GW, Mburu G, Torpey K, Frost P, Ford N, Seeley J. Role and outcomes of community health workers in HIV care in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013 Sep 10;16(1):18586. doi: 10.7448/IAS.16.1.18586.
PubMed 24029015Anyangwe SC, Mtonga C. Inequities in the global health workforce: the greatest impediment to health in sub-Saharan Africa. Int J Environ Res Public Health. 2007 Jun;4(2):93-100. doi: 10.3390/ijerph2007040002.
PubMed 17617671Nance N, Pendo P, Masanja J, Ngilangwa DP, Webb K, Noronha R, McCoy SI. Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial. PLoS One. 2017 Aug 31;12(8):e0181919. doi: 10.1371/journal.pone.0181919. eCollection 2017.
PubMed 28859083
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effectiveness of a Community Health Worker Intervention for HIV-infected Pregnant Women in Tanzania to Improve Treatment Adherence and Retention in Care: A Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT03058484
- Acronym / sponsor ID
- TW7.18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,830 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Amref Health Africa, Ministry of Health and Social Welfare, Tanzania, International Initiative for Impact Evaluation, Organization for Public Health Interventions and Development
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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 implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community.
The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care, i.e. regular clinic services are provided prior to the study. |
| Community Health Worker Intervention | Experimental | Behavioral: Community Health Worker interventionThis arm is a four-part behavioral intervention that includes: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).
Key exclusion criteria (1 listed)
- Did not have sufficient information to link them across registers
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 Health Worker interventionThe intervention included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool. | Behavioural | Community Health Worker Intervention |
Primary outcome
Retention in HIV care
Time frame: 120 days postpartum
Binary variable taking the value of 1 if the women has had at least one clinic visit in the postpartum period (60-120 days after birth), and zero otherwise.
3 secondary outcomes
Adherence to ARVs
Time frame: Birth to 90 days postpartum
Timing of ART initiation
Time frame: ART initiation date, expressed as gestational week of pregnancy, up to 40 weeks
Initiation of ART
Time frame: Through pregnancy and up to 90 days 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 23 Feb 2017.
- Background: PubMed 23509605Hong SY, Jerger L, Jonas A, Badi A, Cohen S, Nachega JB, Parienti JJ, Tang AM, Wanke C, Terrin N, Pereko D, Blom A, Trotter AB, Jordan MR. Medication possession ratio associated with short-term virologic response in individuals initiating antiretroviral therapy in Namibia. PLoS One. 2013;8(2):e56307. doi: 10.1371/journal.pone.0056307. Epub 2013 Feb 28.
- Background: PubMed 19939445Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, Nabiryo C, Ndembi N, Kyomuhangi R, Opio A, Bunnell R, Tappero JW, Mermin J, Coutinho A, Grosskurth H; Jinja trial team. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Lancet. 2009 Dec 19;374(9707):2080-2089. doi: 10.1016/S0140-6736(09)61674-3. Epub 2009 Nov 24.
- Background: PubMed 27118443Geldsetzer P, Yapa HM, Vaikath M, Ogbuoji O, Fox MP, Essajee SM, Negussie EK, Barnighausen T. A systematic review of interventions to improve postpartum retention of women in PMTCT and ART care. J Int AIDS Soc. 2016 Apr 25;19(1):20679. doi: 10.7448/IAS.19.1.20679. eCollection 2016.
- Background: PubMed 24029015Mwai GW, Mburu G, Torpey K, Frost P, Ford N, Seeley J. Role and outcomes of community health workers in HIV care in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2013 Sep 10;16(1):18586. doi: 10.7448/IAS.16.1.18586.
- Background: PubMed 17617671Anyangwe SC, Mtonga C. Inequities in the global health workforce: the greatest impediment to health in sub-Saharan Africa. Int J Environ Res Public Health. 2007 Jun;4(2):93-100. doi: 10.3390/ijerph2007040002.
- Derived from this study: PubMed 28859083Nance N, Pendo P, Masanja J, Ngilangwa DP, Webb K, Noronha R, McCoy SI. Short-term effectiveness of a community health worker intervention for HIV-infected pregnant women in Tanzania to improve treatment adherence and retention in care: A cluster-randomized trial. PLoS One. 2017 Aug 31;12(8):e0181919. doi: 10.1371/journal.pone.0181919. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker intervention in people with Vertical Transmission of Infectious Disease and HIV Infections, run by University of California, Berkeley.
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: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Retention in HIV care (time frame: 120 days postpartum). 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 NCT03058484, 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 23 Feb 2017.