Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02447159 |
| Other study ID # |
CCT for PMTCT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 7, 2015 |
| Last updated |
May 2, 2017 |
| Start date |
August 2015 |
| Est. completion date |
April 2017 |
Study information
| Verified date |
May 2017 |
| Source |
University of California, San Francisco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A randomized controlled trial will be conducted to assess the effectiveness of conditional
cash transfers (CCTs) at increasing retention in prevention of mother-to-child transmission
(PMTCT) services specifically, in relation to pickup of ARV drugs for infected mothers,
delivery in the hospital setting, and receipt of drugs for exposed infants. Administrative
data will be extracted from the All Babies are Equal program and hospital records. At 8-10
weeks after delivery, an endline survey will also be conducted with each participant to
provide a deeper understanding of the impact of the CCTs and to assess the reasons for
retention in PMTCT services.
Description:
Background:
Nigeria, home to only 2% of the world's population, accounts for 30% of the world's
mother-to-child transmissions of HIV. Over the past three years, and in collaboration with
bilateral aid agencies, the Nigerian government has strengthened hundreds of free rural
clinics, trained thousands of birth attendants, and begun free distribution of
antiretroviral (ARV) drugs. Despite this, only 1.8% of low-income women deliver a baby with
a skilled birth attendant, only 16% of HIV-positive pregnant women receive ARVs to prevent
mother-to-child transmission (PMTCT) of HIV, and only 2.3% of infants born to HIV-infected
women received ARV prophylaxis to reduce the risk of virus transmission. Pregnant women are
lost at each step along the PMTCT cascade, from attending a prenatal visit to giving
life-saving antiretroviral therapy to their newborns.
Operated by New Incentives, a non-profit organization focused on maternal and child health,
the All Babies are Equal (ABAE) program was established in June 2014 in Akwa Ibom to improve
utilization of health services for PMTCT. The ABAE program provides conditional cash
transfers (CCTs) to pregnant, HIV-positive women conditional on obtaining specific ante-,
peri-, and postnatal services at public facilities to prevent mother-to-child transmission
of HIV. The CCT is primarily a demand-side intervention that aims to reduce the barriers
that women may face when seeking care, as well as encourage uptake of and retention in PMTCT
services.
Preliminary studies:
A large body of evidence indicates that providing ARV drugs to HIV-positive pregnant women
during pregnancy and at the time of birth to both mother and baby can drastically reduce the
transmission of the virus to the newborn. However, in Nigeria, even though drugs for PMTCT
are free and available, many women do not use them. Additionally, knowledge of
mother-to-child transmission of HIV and PMTCT is high among the investigators' target
population. Recent research shows that 91% of women of reproductive age have high awareness
of PMTCT in southern Nigeria, yet 71% have poor attitudes towards PMTCT treatment and
services, resulting in low uptake of services.
To encourage uptake of PMTCT services, the ABAE's CCT program was designed based on research
that has shown that CCT interventions have increased utilization of health services and
improve child health. CCTs initially used in Latin America provided predictable sums of
money to eligible mothers when certain actions were taken, particularly for health services
and school enrollment. The cash payouts have been shown to alleviate short- and long-term
poverty while building human capital among traditionally underserved populations (i.e. women
and children in impoverished households). CCTs have also been effective for HIV prevention.
For example, in Malawi, schoolgirls (aged 13 to 22) awarded between one and five dollars for
attending school had significantly reduced prevalence of HIV and HSV-2 infection after 18
months. Additionally, several studies have shown that CCTs are an effective way to improve
both access and adherence to antiretroviral therapy and to reduce barriers to maternal and
newborn health service utilization. A CCT program targeted at increasing births in health
facilities in India found a significant increase in uptake of antenatal and intrapartum care
services and an increase in facility-based deliveries. As studies continue to evaluate the
efficacy of CCTs, ongoing efforts aim to determine the impact of these interventions on
transmission of HIV.
This study aims to formally evaluate the ABAE program for increasing retention of
HIV-positive pregnant women in PMTCT through a randomized control trial. Through a
combination of data extracted from the New Incentives program, facility records, and survey
data, the researchers will also investigate the sources of poor attitudes towards PMTCT
services, the influence of non-financial barriers on PMTCT retention, religious and cultural
norms surrounding delivery outside of clinic settings, and how the CCT intervention should
be structured to address the full cascade of PMTCT behaviors without compromising
operational feasibility.
Main hypothesis to be tested:
Conditional cash transfers (CCTs) provided by the All Babies Are Equal (ABAE) program
carried out by New Incentives, a non-governmental organization (NGO), will improve retention
of HIV-positive, pregnant women in prevention of mother-to-child transmission (PMTCT)
services in Akwa Ibom, Nigeria.
Intervention procedures:
Participant Screening:
An ABAE program officer will be stationed at each study site on its respective antenatal
registration (i.e. "Booking day") day from 8am to 6pm. On Booking Day, all women who test
positive for HIV will be recorded on a separate list by the HIV counselor or lab tester on
duty in the privacy of his/her office. For each 1-3 women listed, the names will be
transferred to the ABAE officer who will then transcribe the list in the order that they
appear into a spreadsheet with pre-generated random assignment of women to treatment (i.e.
offered to enroll ABAE program) and control (i.e. not offered the program) groups.
Individuals randomized to the treatment arm will then be approached by the ABAE officer to
screen and verify eligibility in person and against the subject's patient record card.
In-person visit to obtain informed consent:
- Potential subjects that have been randomized to the treatment arm will be directed to a
room where the ABAE program officer will conduct the enrollment process. The ABAE
officer will then describe the program to the woman, discuss confidentiality and
privacy, and see if the woman is interested in participating. ABAE program officers
will follow a standardized enrollment script per the ABAE's standard operating
procedures for enrollment (see supplementary materials). The ABAE officers will explain
both the ABAE program and the accompanying research study, following informed consent
procedures, and obtain written consent for program and study participation. If the
subject agrees to participate in the program, the ABAE program officer will follow a
standardized intake protocol, including survey on background information, to enroll the
woman into the program. She will also be given an informational brochure describing the
program, including requirements to earn the cash rewards. This brochure is written in a
simple language and includes visual graphics to facilitate easy understanding.
- Women receive a small cash payment and mobile phone credits when she completes
enrollment to facilitate retrieval of cash from the bank and return phone call
verification.
Conditional Cash Transfer 1:
- The participant enrolled in the ABAE program will call the New Incentives hotline the
morning after her ANC clinic visit to receive her payment code. If successful, she will
receive the first lump sum cash payment.
Conditional Cash Transfer 2:
- A New Incentives staff member will check the data sources containing information about
medication pickups in the antenatal care ward in the morning of each participating
clinic's Booking Day to check which participants have met the conditions for the second
conditional cash transfer.
- During enrollment, participants are informed to call the New Incentives hotline the
Friday after retrieving their medications for the second time to receive the payment
code for the second lump sum payment.
Conditional Cash Transfer 3:
- A New Incentives staff member will call the participant four to six weeks before her
expected due date to remind her of the third cash transfer. The participant will also
be reminded about facility delivery by an automated robot call and several text
messages.
- A New Incentives staff member will check the Labor Ward Registers in the morning of
each participating clinic's Booking Day to check if study participants have met the
delivery condition of the third conditional cash transfer.
- During enrollment, participants are informed to call the New Incentives hotline the
Friday after birth to receive the payment code for the third lump sum payment.
Conditional Cash Transfer 4:
- A New Incentives staff member will call the participant four to five weeks after she
delivers to remind her of the fourth cash transfer. Furthermore, the participant
receives a text message regarding the early infant diagnosis test that needs to be
taken six weeks after delivery.
- A New Incentives staff member will check the relevant clinic register in the morning of
each participating clinic's Booking Day to check which participants have met the
conditions of the third transfer.
- During a hotline call, participants are informed to call the New Incentives hotline the
Friday after receiving the newborn's early infant diagnosis test to receive the payment
code for the fourth lump sum payment.
Evaluation design:
The effect of the conditional cash transfer program on the primary and secondary outcomes
will be assessed using a randomized control trial. A total of 550 pregnant women testing
positive for HIV will be screened for eligibility and randomized to the 2 arms.
Data collection:
Prior to obtaining consent, the HIV status of all individuals will be collected (this is
standard procedure at participating clinics for ANC enrollment). For women in the control
arm, additional administrative clinic data, including first name, last name, patient number,
pregnant mother number, date of birth, estimated delivery date, month of pregnancy, and
phone number will be collected prior to obtaining informed consent to facilitate record
tracking and later endline phone survey. Personal identifiers, however, will be deleted once
data collection is complete.
There are 3 main sources of data collection:
1. Patient records will be extracted from hospital registers on a weekly basis. Extracted
records will reflect information collated from different facility registers, including
Patient Card, Laboratory Investigation Report Form, Adult Pharmacy Worksheet, ARV
Counselor's worksheet, Daily HIV Test worksheet, Nurses' notebooks, lab testers'
notebook, Delivery Register, Labor Ward Daily Report Book, Admissions Register, Child
Follow-up Register, Dried Blood Spot Specimen Transport Form, and the Pediatric
Pharmacy worksheet.
2. ABAE program data for women in the treatment arm participating in the conditional cash
transfer program. These data include the information on program participants obtained
through the program enrollment survey, interim telephone calls and questionnaires, and
records of cash transfers.
3. An endline phone survey will be administered to all women enrolled in the study for
which a valid phone number has been obtained (8-10 weeks after delivery).
- At this point, the New Incentives employee will verify the subject's
identification (i.e. recently was pregnant and registered for antenatal services
at the specific participating clinic) and obtain verbal informed consent to
participate in the endline survey.
- This is the only contact that control subjects will have with the study personnel.
- All individuals completing the phone survey will receive a small amount mobile
phone credits as compensation for their time.
- The endline survey will ask participants about women's birth history,
decision-making over place of delivery, perceptions on program participation (if
enrolled in the ABAE program), a discrete choice experiment to elicit state
preferences over place of delivery (only for women randomized to the control arm),
and sociodemographic background.
Data analysis:
1. Overall program effect:
Our basic analysis will be to calculate point estimates (e.g., achievement of each cash
transfer condition) with reasonable precision (i.e., the margin of error) for program
participants and non-participants overall and for key sub-categories (e.g., at each
facility) based on data abstracted from hospital records. We will first calculate
univariate statistics, such as mean retention for each PMTCT condition and standard
deviations, for program participants and non-participants, and means and standard
deviations for key sub-categories. We will then test whether retention percentages are
different between participants and non-participants with 2-tailed chi-squared tests of
proportions with significance at α=0.05. We can test for independent effects,
confounding, and interactions in multivariate analysis. Logistic regression analyses
will be used to test for autocorrelation between subjects enrolled at the same
facility, and hausman tests will be used to assess the relative fit of facility random
and fixed effects. Possible sources of confounding include differences in HIV testing
procedures and collection of patient records across facilities and over time (e.g. due
to holidays, agricultural seasons). For example, logistic regression predicting the
likelihood of delivering at the facility where ANC was sought can be used to
simultaneously assess the independent effect of program participation while controlling
for facility site, stage of pregnancy when enrolled, and time. Sensitivity analyses
will be conducted to account for known sources of attrition (e.g. participant
requesting to be dis-enrolled) and/or potential sources of spillover across study arms
(e.g. women in the control group reporting that they had heard about the ABAE program).
2. Assess the differences in program attrition and self-reported attitudes and behaviors
between control and treatment arms.
With responses from the phone follow-up survey, which will be affected by unknown
sources of attrition, the study of self-reported behaviors and perceptions is not
designed to test one central hypothesis, but will involve exploratory statistical
testing of differences in self-reported behaviors and perceptions among program
participants vs. non-participants overall, and by key sub-categories (e.g.
sociodemographic characteristics, location of residence). Standard multiple linear
regression analysis will be used to assess individual determinants of outcomes and
changes in outcomes for continuous outcomes. Logistic regression analysis will be used
for dichotomous outcomes. For ordered categorical outcomes, count data, or potentially
censored outcomes, we will first assess whether a binomial, poisson, or negative
binomial distribution is appropriate by examining each outcome's dispersion. Depending
on the specification tests in #1 above, additional adjustments of autocorrelation will
be included. Wealth indices will be constructed using standardized methods following
Filmer and Pritchett (2005).
3. Assess the existence of heterogeneous treatment effects. Multivariate regression also
allows for testing interactions, such as whether program participation retention rates
are different for different groups of patients (e.g., by stage of pregnancy, facility,
a newly diagnosed HIV case, age).
4. Determine women's stated preferences for facility-based deliveries. We will complement
our primary analysis with a discrete choice experiment (DCE). The DCE is designed to
solicit respondents' preferences over several key childbirth or delivery
characteristics. Each DCE question asks respondents to state a preference for
hypothetical options A or B. First, for each question, we will use comparison of means
(and Chi-squared tests) and regression analysis (and t-tests) to compare the proportion
of respondents indicating A to the proportion indicating B. Second, using the same
statistical tools, we will pool questions with overlapping characteristics and measure
the change in stated choice associated with a particularly delivery characteristic.
Enrollment projection:
Sample sizes were calculated assuming a baseline delivery and drug pickup rate of 50%, which
produced the largest possible variance. A conservative estimate of the effect of the
intervention would be from a 50% baseline of delivery rates and drug collection to 70% after
the intervention. Such results would have 99.9% power if each group consists of 250 people.
Contrary to these conservative calculations assuming a 50% baseline, the baseline rate of
delivery is approximately 30% at clinic sites and drug pickup rates are even lower,
according to the clinic data. We therefore expect the study results to have 100% power.
Power calculations were carried out using the DS Research online power calculator. An
additional 10% upward adjustment is made to account for possible refusals to participate.
Study sites:
General Hospital, Ikot Ekpene, Akwa Ibom State, Nigeria General Hospital, Iquita Oron, Akwa
Ibom State, Nigeria Immanuel General Hospital, Eket, Akwa Ibom State, Nigeria
