Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03517878
Other study ID # N14/03/019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 11, 2014
Est. completion date June 1, 2018

Study information

Verified date October 2018
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this early Phase 2 comparison trial is to evaluate the impact of community health worker (CHW) home visitors on pregnant women and their children in a rural setting in the rural Eastern Cape of South Africa. The intervention provided by the CHWs targets underweight children, mothers living with HIV (MLH), mothers using alcohol, and depressed mothers with the goal of supporting pregnant women to improve birth outcomes, decrease the number of children born with a low birthweight, and develop child caretaking skills over time. UCLA has identified and matched four areas surrounding primary health care clinics: two intervention areas in which this CHW program has been running for one year, and two control areas without the program. Mothers in the research area are followed for one year after giving birth.


Description:

Inequalities in the quality and accessibility of healthcare between urban centers and rural areas is a global challenge that is particularly stark for low and middle-income countries (LMIC). Maternal and child health (MCH) in rural South Africa is negatively impacted by large distances, poor infrastructure, and a shortage of healthcare workers at clinics and hospitals.

Home visiting has been repeatedly demonstrated efficacious in addressing some of these challenges and improving MCH outcomes, including when delivered by CHW in LMIC. However, there is limited research on the effectiveness of implementing these types of programs in rural areas.

The investigators have shown that with training, supervision, and accountability, CHW home visits are effective in improving MCH over the first five years of life. These results were observed in a successful randomized controlled trial conducted in peri-urban townships in Cape Town, South Africa. CHW were trained to address HIV, alcohol, and malnutrition among all pregnant women in a neighborhood, to avoid stigma, and to address multiple health challenges concurrently. The visits significantly improved MCH outcomes over five years. Based on these results, this comprehensive CHW home visiting program served as one model for re-engineering primary health care to include 65,000 paraprofessionals providing home-based care in South Africa.

This early phase two comparison trial examines whether the same comprehensive CHW home visiting program can be effectively implemented in a deeply rural area of the Eastern Cape in South Africa. Two matched cohorts of women and their children, one in areas where the comprehensive CHW program has been active for one year and one in areas without the program, will be followed from pregnancy through the first 12 months after giving birth. Stellenbosch University interviewers will independently assess outcomes of each mother at pregnancy, and of the mothers and infants within two weeks of post-birth, 6 months, and 12 months later. The primary outcomes are a combined measures of maternal and child health including maternal HIV testing, depression, and alcohol use, as well as the child's nutrition, physical growth, development, and healthcare and a measure of how MLH comply with tasks for PMTCT.


Recruitment information / eligibility

Status Completed
Enrollment 1490
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Pregnant women who are or become mothers living in the catchment area at the time of recruitment

- Women not identified as psychotic or delusional based on the interviewer's judgment

- Women able to provide informed consent

Exclusion Criteria:

- Inability to give informed consent

- Inability to converse with the interviewer or the CHW

- Miscarriage or stillbirth

- Death of the infant

- Death of the mother

Study Design


Intervention

Behavioral:
Comprehensive CHW Program
The comprehensive CHW Cohort will receive home visits from CHWs recruited, trained, and supervised by the Philani organization. Philani has a 30-year history of non-stigmatizing home-based support for women and children in Cape Town. The organization has been operating their comprehensive CHW program in the rural Eastern Cape since 2010; however, in the research areas, CHWs have only been active for one year prior to initiation of the study. Philani recruits CHWs that are "positive peer deviants" to serve as role models in the community. The CHWs then receive training, materials, and skills to address major community health challenges of HIV, TB, malnutrition, alcohol use, and depression. The CHWs also receive ongoing monitoring and supervision as well as support for difficult cases.

Locations

Country Name City State
South Africa Zithulele Hospital Mqanduli Eastern Cape
South Africa Stellenbosch University Stellenbosch

Sponsors (4)

Lead Sponsor Collaborator
University of California, Los Angeles Philani Maternal Child Health and Nutrition Project, The ELMA Foundation, University of Stellenbosch

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite outcome: Number of significantly improved child and maternal outcomes Out of 11 variables, we run 1000 simulations on the distribution of 0 and 1. The investigators total number of outcomes (each scored as 0=not present or 1=present) and determine if the Comprehensive CHW Cohort sum is significantly greater than expected based on the Control Cohort.
For Mothers:
Breastfeeding
No alcohol in pregnancy
Not depressed
Adhere to medical regimens
For all mothers:
-4 antenatal care visits
For HIV+ mothers:
Test for HIV
Take ARV
Give infant NVP and bactrim
infant PCR
exclusive breastfeeding
For Children:
Not low birth weight
Growth in height
Growth in weight
Hospitalizations
Developmental milestones
Vaccinations
Child support grant
Harwood JM, Weiss RE, Comulada WS. Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes. Prevention Science. 2017 Jul 1;18(5):526-33.
12 months
Secondary Breastfeed for three months Mothers are asked at the 6 month and 12 month follow up "How long after your baby's birth did you stop breastfeeding your baby completely?" 6 months, 12 months
Secondary Breastfeed for six months Mothers are asked at the 6 month and 12 month follow up "How long after your baby's birth did you stop breastfeeding your baby completely?" 6 months, 12 months
Secondary No alcohol after learning that the participant was pregnant At the birth interview mothers are asked "Have you ever used alcohol during this pregnancy?" and follows up with "Did you continue to drink alcohol after you knew you were pregnant?" Birth
Secondary Attend 4 antenatal care visits At the birth interview antenatal care cards are inspected and mothers are asked "How many antenatal care visits did you attend?" Birth
Secondary Not depressed, EPDS below 13 EPDS is asked after birth, 6 months after birth, and at 12 months after birth. Birth, 6 months, 12 months
Secondary Infant was not low birth weight Birth weight is recorded from child's road to health card and baby is weighed by data collector shortly after birth (this value is used when road to health card is not available). Birth
Secondary Growth in height-for-age (above -2SD) Child height/length is recorded shortly after birth, at 6 months, and at 12 months. Values are compared to WHO norms and turned into a Z score. Birth, 6 months, 12 months
Secondary Growth in weight-for-age (above -2SD) Child weight is recorded shortly after birth, at 6 months, and at 12 months. Values are compared to WHO norms and turned into a Z score. Birth, 6 months, 12 months
Secondary Number of Hospitalizations At 6 months and 12 months after birth mothers are asked "During the past 3 months, have you taken the child to the hospital for any reason?" and "How many times have you taken the child to the hospital?" 6 months, 12 months
Secondary WHO developmental scale measures at 50th percentile WHO measures of child development are used and children are compared to the mean level of achievement for their age. Fussy or sleepy children may be unable to be evaluated. 12 months
Secondary Vaccinations up to date Data collectors examine the child's road to health card to determine if all immunizations are up to date and which ones are missing. A photo is taken of this page for confirmation. 12 months
Secondary Has Child Support Grant Mothers are asked "Does the child get a child support grant?" 12 months
Secondary Mothers test for HIV during pregnancy Data collectors look for any evidence on the antenatal card of an HIV test during pregnancy. If not, or if card is unavailable, check with the mother if she has previously tested positive for HIV or ask "Did you have a test for HIV during this pregnancy?" Birth
Secondary MLH take ARV during pregnancy Mothers are asked "When did you start taking ARVs?" and antenatal cards and health cards are examined for evidence of ARV prescription and start date. 12 months
Secondary Give infant NVP and Bactrim Mothers are asked "Did you get Nevarapine syrup for your baby around the time of birth?"; "Are you currently using nevirapine syrup for the baby?" and "Are you currently still giving your child bactrim?" 6 months
Secondary PCR testing at 6 weeks Mothers are asked "Has you child been tested for HIV yet?" and "Do you know what the result of your child's HIV test (PCR) is?" Data collectors independently confirm this information on the child's road to health card to determine how many times (if at all) the child has been tested for HIV? 12 months
Secondary 6 months exclusive breastfeeding Mothers are asked "How soon after birth did you give your child something else in addition to breastmilk?" In addition, mothers are asked to provide a 24 hour, 1 months, and 3 month dietary recall. 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Recruiting NCT03256435 - PrEP Intervention for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Enrolling by invitation NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2
Recruiting NCT03701802 - Immunogenetic Modulators of Mucosal Protection From HIV-1
Recruiting NCT03271307 - Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners N/A
Recruiting NCT03684655 - Imaging Immune Activation in HIV by PET-MR Phase 1
Recruiting NCT03577782 - Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy Phase 1/Phase 2
Not yet recruiting NCT03682939 - Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population Phase 4
Active, not recruiting NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Active, not recruiting NCT01937455 - A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults. Phase 1
Withdrawn NCT01975012 - Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Active, not recruiting NCT01931358 - Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E Phase 2
Completed NCT01968551 - Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults Phase 3
Completed NCT01923610 - Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B Phase 1