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NOURISH: Nutrition and empowerment: evidence from women living with HIV in Uganda
Last registered on September 28, 2017

Pre-Trial

Trial Information
General Information
Title
NOURISH: Nutrition and empowerment: evidence from women living with HIV in Uganda
RCT ID
AEARCTR-0000447
Initial registration date
July 21, 2014
Last updated
September 28, 2017 4:15 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
Trinity College Dublin
Other Primary Investigator(s)
PI Affiliation
Trinity College Dublin
Additional Trial Information
Status
Completed
Start date
2014-04-01
End date
2015-12-31
Secondary IDs
Abstract
HIV can overcome host defence mechanisms by infecting and destroying the immune system, thereby creating immunodeficiency which results in susceptibility to opportunistic infections. Antiretroviral drugs (ARVs) can inhibit viral replication and boost immune competence, halting the progression to AIDS. However, malnutrition is a major cause of immunodeficiency and efforts to control HIV are compromised by the presence of co-morbid malnutrition. Uganda’s national response to HIV/AIDS is recognised as strong and effective with prevalence dropping to 6% nationally and the numbers of patients receiving Antiretroviral Therapy rising to 140,000. However, prevalence is rising again in certain populations and many people living with HIV particularly in rural areas still do not have access to the Antiretroviral (ARV) services they need. Moreover, despite efforts by the Ugandan Ministry for Health to boost the nutritional aspects of HIV care a significant percentage of those attending for treatment have mild to moderate malnutrition and do not receive supplementary feeding under the present criteria. The aim of this project is to test a variety of nutrition related interventions to assess their impact on health and welfare outcomes, their impact on behavior in relation to nutrition and the mechanisms through which changes in behavior occur. Our interventions aim to both inform women on the importance of nutrition and how to fulfil their nutritional needs but also how to empower women to improve outcomes for them and their children in a sustainable way. The interventions are based around information provision to women attending clinics for HIV treatment. Specifically we consider three interventions that are simple, cost effective and scalable: 1) a nutritional information campaign; 2) cookery demonstrations on how to produce locally sourced home-made nutritious food; 3) an empowerment intervention involving videos of business success stories of women living in similar circumstances to the participants in our study. Our identification strategy aims to establish causal connections between different types of campaigns and also aims to disentangle underlying mechanisms including the existence of general information constraints; the medium of disseminating information; food insecurity and access to resources; and intra-household considerations. We test interventions across 4 representative sub-regions of Uganda improving the external validity and policy relevance.
External Link(s)
Registration Citation
Citation
Narciso, Gaia and Carol Newman. 2017. "NOURISH: Nutrition and empowerment: evidence from women living with HIV in Uganda." AEA RCT Registry. September 28. https://doi.org/10.1257/rct.447-2.0.
Former Citation
Narciso, Gaia and Carol Newman. 2017. "NOURISH: Nutrition and empowerment: evidence from women living with HIV in Uganda." AEA RCT Registry. September 28. https://www.socialscienceregistry.org/trials/447/history/21876.
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Experimental Details
Interventions
Intervention(s)
Intervention 1: Nutrition information campaign in the form of leaflets and posters delivered to treatment clinics. Simple message regarding every day nutrition provided along with a recipe for preparing a Home-made Nutritious Food using locally sourced ingredients. Recipes are developed as part of the project and laboratory tested and tested in the field for each of the four regions in Uganda covered by the study.

Intervention 2: Nutrition information campaign (as above) and cookery demonstrations on how to prepare the Home-made Nutritious Food at clinics during Women's regular appointments.

Intervention 3: Empowerment campaign involving short 3-4 minute videos of local women in similar situations to participants in the study who have developed a successful business. The stories told aim to inspire participants in the study. Videos are tailor made to each of the 4 regions included in the study and will be shown to participants at their regular clinic appointments. Each video will be followed by a focus group type discussion.
Intervention Start Date
2014-10-13
Intervention End Date
2015-09-30
Primary Outcomes
Primary Outcomes (end points)
Nutrition and Health outcomes
1. Impact of improved nutritional information on nutrition and health outcomes

Identification: Test differences in outcomes between control group and group that receives nutritional information campaign delivered in a standard way.

2. Impact of information on local sourcing and preparation of home-made nutritious food on nutrition and health outcomes

Identification: Test differences in outcomes between group that receives nutritional information campaign delivered in a standard way and group that received the campaign and demonstrations in how to prepare a locally-sourced home-made nutrition food. The focus will be on testing whether information can have an impact and whether the type of information and medium through which information is transmitted matters for outcomes. To disentangle the mechanisms we will look at the differential impact on changes in the types of foods households consume; the adoption and use of locally sourced ingredients for the preparation of the home-made nutritious food; and agricultural production decisions.

The role of female empowerment

3. Impact of female empowerment through the use of videos of success stories of local women in similar circumstances on nutrition and health outcomes

Identification: Test differences in outcomes between control group and group that receive the video intervention. To disentangle the underlying mechanisms we will look at the impact of the intervention on household income and relative income of women within the household and examine the various mechanisms through which improved nutrition, health and welfare outcomes are achieved.
Primary Outcomes (explanation)
Outcomes to be considered:
Food consumption
Agricultural production
Child welfare (health status, school enrollment, school attendance)
Micro-enterprise development
Savings behavior
Access and use of credit
Female employment
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
4 sub-regions of Uganda randomly selected
Within each sub-region 8 clinics are randomly selected
At baseline each clinic is visited for two days to recruit participants
130 women recruited at each clinic and are offered a small incentive to participate in the form of a travel refund
Three separate interventions are considered and randomization of baseline participants occurs at the clinic level. Clinics are randomly assigned into 4 groups:

Group A Control group
Group B Information campaign
Group C Information campaign and cookery demonstrations on home-made nutritious food
Group D Empowerment course

Each group will include 8 clinics and will be evenly distributed across each of the 4 sub-regions

After baseline data have been collected participants are visited 4 times over the course of a year at each of their scheduled appointments at the clinic.
Appointment cards will be issued at baseline and participants will be texted a week before and a day before their appointments to ensure that they attend the clinic on the scheduled day.
Evaluation will take place six months into the intervention period and one year after the interventions begin.

Timeline
April-September 2014 – Baseline
October-December 2014 – Treatment 1
January – March 2015 – Treatment 2
April –June 2015 – Treatment 3 and Evaluation 1
July – September 2015 – Treatment 4
October – December 2015 – Evaluation 2
Experimental Design Details
Randomization Method
Randomization done in office by a computer
Randomization Unit
We use a multisite (or blocked) cluster randomized trial with person-level outcomes
The ‘sites’ or ‘blocked clusters’ refer four sub-regions of Uganda
Overall 30 districts were selected on the basis of HIV prevalence
These districts were grouped into 4 sub-regions
The 4 sub-regions were sampled on the basis of Proportional to Size Sampling
Within each region 8 clinics are randomly from the population of clinics
We consider Health Clinics level III (catchment area of 20,000 people) and IV (catchment area of 100,000 people) as these are the ones that run regular HIV clinics
At baseline we recruit 130 women at each the clinic
Our total sample size at baseline will be approximately 4,000 women
A small incentive in the form of a travel refund is offered for participation on each day that the team is present at the clinics
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
32 clinics drawn randomly from 4 sites
Sample size: planned number of observations
130 women at each the clinic leading to a total sample at baseline of approximately 4,000 women
Sample size (or number of clusters) by treatment arms
8 clinics control, 8 clinics nutritional information campaign, 8 clinics nutritional information campaign and cookery demonstrations, 8 clinics empowerment intervention
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Uganda National Council for Science and Technology
IRB Approval Date
2014-03-11
IRB Approval Number
HS 1577
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
August 31, 2015, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
December 31, 2015, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
32 HIV clinics
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
3,811 women
Final Sample Size (or Number of Clusters) by Treatment Arms
8 clinics control, 8 clinics role models intervention, 8 clinics nutrition information campaign, 8 clinics nutrition information campaign and cookery demonstration.
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers