Clinical trial NCT02332265: Evaluation of the Effects of a Structural Economic and Food Security Intervention on HIV Vulnerability in Rural Malawi
Official title: Pathways Linking Poverty, Food Insecurity, and HIV in Rural Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Food Security
Microfinance
Village Savings and Loans
HIV
Quasi-experimental design
Malawi
Structural intervention
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: CARE Malawi
name: University of Pennsylvania
name: University of Malawi
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-01-06
Enrollment: 1901
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \[Study 1\] Random selection of households chosen by CARE-Malawi to participate in SAFE intervention residing in Mwase, Kaomba, or Njombwa Traditional Authorities in Malawi. These households are compared to household not receiving the CARE-Malawi SAFE intervention residing in Lukwa, Kawamba, or Chaima.

\[Study 2\] Random selection of households in program TAs (Mwase, Kaomba, or Njombwa) including households not receiving intervention. This sample is compared to a random selection of households residing in non-intervention areas TAs (Lukwa, Kawamba, or Chaima).

\[Study 3\] Random selection of individuals participating in SAFE intervention within intervention TAs.

Brief summary: The purpose of this study is to evaluate a multilevel economic and food security program (Support to Able-Bodied Vulnerable groups to Achieve Food Security; SAFE) in rural central Malawi as implemented and assigned by CARE-Malawi on HIV vulnerability and other health outcomes.

Hypothesis: HIV vulnerability can be reduced through a coordinated set of locally tailored individual and structural interventions that reduces poverty, reduces food insecurity, strengthens community bonds, and addresses gender inequality.

Detailed description: Purpose:

Poverty and lack of a predictable, stable source of food are two fundamental determinants of ill health, including HIV/AIDS. Conversely, episodes of poor health and death from HIV can disrupt the ability to maintain economic stability in affected households, especially those that rely on subsistence farming. However, little empirical research has examined if, and how, improvements in people's economic status and food security translate into changes in HIV vulnerability.

The purpose of the SAGE4Health study is therefore to evaluate a large-scale economic development program implemented by CARE-Malawi to examine mechanisms and magnitude of impact on economic livelihoods, food security, and health. Specifically, the study aims to examine how socioeconomic changes may affect vulnerability to HIV and other risks that can overwhelm rural households in subsistence environments.

To contextualize the study location, it is important to note that HIV/AIDS, poverty and food insecurity contribute substantially to morbidity and mortality in sub-Saharan Africa. The Republic of Malawi, in southeastern Africa, bears one of the heaviest HIV disease burdens globally. Poverty is endemic in Malawi; more than half of its estimated 15 million people live on less than a dollar a day. Food insecurity, defined as having uncertain or limited access to nutritionally adequate food, or being unable to procure food in socially acceptable ways, is an aggravated problem in Malawi.

To better understand the context of HIV in Malawi, and to determine potential responses, it is important to consider HIV within an ecosocial framework. Moving beyond the conventional focus on proximal factors contributing to HIV vulnerability, like individual risk behaviors, it is essential that interventions address poverty and food insecurity as interrelated distal factors in the HIV pandemic, especially in countries like Malawi. Poverty has been consistently recognized as a risk factor for food insecurity and HIV, and food insecurity a risk factor for poor HIV-related outcomes.

Increasing critique has targeted the limitations of proximally focused HIV prevention interventions and emphasizes the need for the development and assessment of complex, multilayered structural interventions that address root causes and causal pathways linking social, economic, political and environmental factors to HIV risk, and vulnerability in specific contexts.There are significant gaps in knowledge, however, about the development, implementation and evaluation of structural interventions. First, while integration of food security interventions into HIV/AIDS prevention programs is essential to curtail the HIV/AIDS pandemic and improve health and quality of life among those infected in resource-poor settings, the literature has offered little guidance to international policy makers, such as the World Food Programme. To our knowledge, there have been no published intervention studies examining the impact of economic status and food security on HIV outcomes in Malawi.

Second, complex multilevel structural interventions are expensive. Typically, non-governmental organizations (NGOs), or government agencies implement them. The cost and complexity of study designs that would adequately evaluate real-world structural interventions do not align well with the typical NIH-funded randomized control trial (RCT) model; this presumably could explain the dearth of research.

Third, major challenges remain in evaluating the impact of structural interventions. Few NGO interventions are evaluated rigorously to rule out alternative explanations for success. Perhaps most importantly, few NGO program evaluations involve a control group. Further, most structural intervention assessments are limited to either structural variables on which they directly intervene (such as social norms that condone intimate-partner violence or microcredit program use rates) or key HIV health outcomes only. These research gaps in the development, implementation and evaluation of structural interventions limit their wider dissemination and scale-up in resource-poor countries, where services are much needed.

The SAGE4Health longitudinal study represents one of the first attempts to understand the mechanisms and processes through which changes in food security and economic outcomes (i.e., income, household assets, livelihood options) can impact HIV vulnerability (i.e., HIV risk behaviors, malnutrition, HIV infections). It also represents one of the first NIH-funded studies based on an academic-economic development NGO partnership. This type of partnership leverages strengths of NGOs (i.e., their ability to respond quickly to crises and their capacity for large-scale, sustainable development work) and the excellence of HIV/AIDS researchers' rigorous study designs and evaluations. In addition to examining pathways linking distal ecosocial factors to HIV vulnerability, this study will provide important information for understanding the impact of multilevel structural interventions on HIV with the potential for sustainable long-term public health benefits. Finally, this collaboration provides a unique opportunity to conduct a detailed study of a multilevel intervention on a scale unlikely to be supported entirely by NIH research funding; in effect, we use the NIH and NGO program funding to enhance both contributions.

Description:

SAGE4Health is a five-year academic-NGO collaboration evaluating the mechanisms and magnitude of the impact of a multilevel economic and food security program (Support to Able-Bodied Vulnerable groups to Achieve Food Security; SAFE), as implemented by CARE-Malawi.

The study is being conducted in the rural areas of the Kasungu District of central Malawi. Among Malawian adults aged 15-49, approximately 11% live with HIV. In Malawi, 74% of people live below the international poverty line of US$1.25 per day. The Malawi economy is dominated by the agriculture sector, which employs 80% of the population, accounts for 42% of national GDP, supplies 81% of foreign exchange earnings and contributes significantly to national and household food security. Aside from agriculture, Malawi's economy is also highly influenced by foreign aid. Based on the World Bank Africa Development Indicators 2011 Report, the foreign aid accounted for 16.3% of Malawi's GDP in 2009. Given that Malawi's economy receives substantial amounts of assistance, there is great interest from both donors and the Malawian government to understand the types of interventions that effectively create sustainable change in both the health and economic sectors.

(see intervention description for full details of SAFE intervention)

SAGE4Health Sample 1: Longitudinal, quasi-experimental, nonequivalent-control group design. Objective: examine impact of SAFE intervention on economic status, food security, HIV/AIDS vulnerability and other health-related outcomes at the SAFE program participants' level. Sample: Participants (n =598) from three Traditional Authorities (TAs) who received SAFE intervention (intervention group) are compared with 301 participants who live in three other matched TAs (control group, matched on demographics and distance from an urban center) not receiving SAFE. Quantitative data was collected in three waves: Baseline (during year 2009), 18-month, and 36-month follow up.

SAGE4Health Sample 2: Random sample community survey with a cohort sequential design. Objective: check the possible threats (i.e., other external factors such as Malawi's national fertilizer and seed programs that were introduced in the same period as the intervention) to the internal validity of the intervention/evaluation by examining whether the intervention effects were the results of something plausible during the study period, in the larger communities where the intervention was delivered. Sample: 500 randomly selected villages in SAFE TAs that were not direct participants in the SAFE program; 500 control TAs, where the SAFE program had not been implemented. Quantitative data was collected in three waves: Baseline (during year 2009), 18-month, and 36-month follow up.

SAGE4Health Sample 3: Series of in-depth qualitative interviews and focus groups conducted 18 months after enrollment near the end of SAFE program implementation. Objective: understand SAFE participants' experiences in the program, their perceptions of its impact and their perspectives on the phenomena. Sample: 90 individuals participating in both focus group discussions and in-depth interviews.

Eligibility criteria: Inclusion criteria:

* \[Study 1: Prospective participant sample (intervention) and Study 3: End-of-program implementation qualitative sample\] (intervention) Participant household in CARE-Malawi SAFE intervention residing in one of three selected study Traditional Authorities
* \[Study 1: Prospective control sample\] (control) Non-recipients of CARE-Malawi SAFE intervention residing in one of three matched (on demographics and distance from an urban center) Traditional Authorities
* \[Study 2: Cross-sectional community sample\] (intervention) Non-participant-household in CARE-Malawi SAFE intervention residing in SAFE intervention Traditional Authority
* \[Study 2: Cross-sectional community sample\] (control) Non-participant-household in CARE-Malawi SAFE intervention not residing in SAFE intervention Traditional Authority

Exclusion criteria:

-\[Study 1, 2, and 3\] household located in non-study or non-control area Traditional Authority

Primary outcomes:
measure: Change in economic status
timeFrame: Change in economic status between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention)
measure: Change in food security
timeFrame: Change in food security between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention)
measure: Change in HIV vulnerability
timeFrame: Change in HIV vulnerability between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
Secondary outcomes:
measure: Change in dietary diversity
timeFrame: Change in household dietary diversity between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in household perceptions of poverty
timeFrame: Change in household perceptions of poverty between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in household access to services
timeFrame: Change in household access to services between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in sustainable agriculture practices
timeFrame: Change in sustainable agriculture practices between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in personal health
timeFrame: Change in personal health between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in acute and chronic illness
timeFrame: Change in acute and chronic illness between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in childbirth experiences
timeFrame: Change in childbirth experiences between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in family planning
timeFrame: Change in family planning between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in self-reported STD infections
timeFrame: Change in self-reported STD infections between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in perceived HIV/AIDS stigma
timeFrame: Change in perceived HIV/AIDS stigma between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in self-reported male circumcision prevalence and attitudes
timeFrame: Change in self-reported male circumcision prevalence and attitudes between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in gender power attitudes
timeFrame: Change in gender power attitudes between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
measure: Change in community cohesion
timeFrame: Change in community cohesion between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: CARE International-Malawi
Study officials:
affiliation: University of Wisconsin, Milwaukee, Zilber School of Public Health
name: Lance Weinhardt, PhD
role: PRINCIPAL_INVESTIGATOR
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