Evaluation of the Effects of a Structural Economic and Food Security Intervention on HIV Vulnerability in Rural Malawi

HIV Clinical Trial

— SAGE4Health  

Official title:

Pathways Linking Poverty, Food Insecurity, and HIV in Rural Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332265
• Other study ID #: 144-PRJ51ZT
• Secondary ID: R01HD055868
• Status: Completed
• Phase: N/A
• First received: December 21, 2014
• Last updated: January 2, 2015
• Start date: February 2009
• Est. completion date: April 2012

Study information

• Verified date: January 2015
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMalawi: National Health Sciences Research CommitteeUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1901
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Support to Able-Bodied Vulnerable groups to Achieve Food Security (SAFE)
The SAFE program was developed & implemented from Jan. 2008-Dec. 2010 by CARE-Malawi, a country office of CARE International, a large NGO. SAFE participants were selected by CARE-Malawi. SAFE was designed to address intertwined structural issues contributing to HIV susceptibility: food insecurity, poverty, gender inequity and ineffective governance. SAFE was implemented in 3 geographic subdivisions (Njombwa, Kaomba, & Mwase) of Kasungu District, located in west-central Malawi. It was funded primarily by the European Commission & partially by the Austrian Development Cooperation. SAFE had 4 main components: 1) improving farming practices & sustainable agriculture through Farmer Field Schools, 2) increasing access to savings and investment through Village Savings & Loans Groups, 3) building capacity of local governance structures & 4) integrating HIV education & gender empowerment into programs through training & education. Details: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082534/.

Locations

Country	Name	City	State
Malawi	CARE International-Malawi	Lilongwe

Sponsors (5)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	CARE Malawi, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Malawi, University of Pennsylvania

Country where clinical trial is conducted

Malawi, 

References & Publications (16)

Bonell C, Fletcher A, Morton M, Lorenc T, Moore L. Realist randomised controlled trials: a new approach to evaluating complex public health interventions. Soc Sci Med. 2012 Dec;75(12):2299-306. doi: 10.1016/j.socscimed.2012.08.032. Epub 2012 Sep 7. — View Citation

Bonell CP, Hargreaves J, Cousens S, Ross D, Hayes R, Petticrew M, Kirkwood BR. Alternatives to randomisation in the evaluation of public health interventions: design challenges and solutions. J Epidemiol Community Health. 2011 Jul;65(7):582-7. doi: 10.1136/jech.2008.082602. Epub 2009 Feb 12. Review. — View Citation

Dworkin SL, Blankenship K. Microfinance and HIV/AIDS prevention: assessing its promise and limitations. AIDS Behav. 2009 Jun;13(3):462-9. doi: 10.1007/s10461-009-9532-3. Epub 2009 Mar 18. — View Citation

Gupta GR, Parkhurst JO, Ogden JA, Aggleton P, Mahal A. Structural approaches to HIV prevention. Lancet. 2008 Aug 30;372(9640):764-75. doi: 10.1016/S0140-6736(08)60887-9. Epub 2008 Aug 5. Review. — View Citation

Krieger N. Epidemiology and the web of causation: has anyone seen the spider? Soc Sci Med. 1994 Oct;39(7):887-903. Review. — View Citation

Laga M, Rugg D, Peersman G, Ainsworth M. Evaluating HIV prevention effectiveness: the perfect as the enemy of the good. AIDS. 2012 Apr 24;26(7):779-83. doi: 10.1097/QAD.0b013e328351e7fb. — View Citation

Miller CL, Bangsberg DR, Tuller DM, Senkungu J, Kawuma A, Frongillo EA, Weiser SD. Food insecurity and sexual risk in an HIV endemic community in Uganda. AIDS Behav. 2011 Oct;15(7):1512-9. doi: 10.1007/s10461-010-9693-0. — View Citation

Mkandawire-Valhmu L, Stevens PE. The critical value of focus group discussions in research with women living with HIV in Malawi. Qual Health Res. 2010 May;20(5):684-96. doi: 10.1177/1049732309354283. Epub 2009 Nov 19. — View Citation

Pronyk PM, Hargreaves JR, Kim JC, Morison LA, Phetla G, Watts C, Busza J, Porter JD. Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial. Lancet. 2006 Dec 2;368(9551):1973-83. — View Citation

Pronyk PM, Kim JC, Abramsky T, Phetla G, Hargreaves JR, Morison LA, Watts C, Busza J, Porter JD. A combined microfinance and training intervention can reduce HIV risk behaviour in young female participants. AIDS. 2008 Aug 20;22(13):1659-65. doi: 10.1097/QAD.0b013e328307a040. — View Citation

Sepúlveda J. The 'third wave' of HIV prevention: filling gaps in integrated interventions, knowledge, and funding. Health Aff (Millwood). 2012 Jul;31(7):1545-52. doi: 10.1377/hlthaff.2012.0314. — View Citation

Sumartojo E. Structural factors in HIV prevention: concepts, examples, and implications for research. AIDS. 2000 Jun;14 Suppl 1:S3-10. — View Citation

Victora CG, Habicht JP, Bryce J. Evidence-based public health: moving beyond randomized trials. Am J Public Health. 2004 Mar;94(3):400-5. — View Citation

Weinhardt LS, Galvao LW, Mwenyekonde T, Grande KM, Stevens P, Yan AF, Mkandawire-Valhmu L, Masanjala W, Kibicho J, Ngui E, Emer L, Watkins SC. Methods and protocol of a mixed method quasi-experiment to evaluate the effects of a structural economic and food security intervention on HIV vulnerability in rural Malawi: The SAGE4Health Study. Springerplus. 2014 Jun 12;3:296. doi: 10.1186/2193-1801-3-296. eCollection 2014. — View Citation

Weinhardt LS, Galvão LW, Stevens PE, Masanjala WH, Bryant C, Ng'ombe T. Broadening research on microfinance and related strategies for HIV prevention: commentary on Dworkin and Blankenship (2009). AIDS Behav. 2009 Jun;13(3):470-3. doi: 10.1007/s10461-009-9561-y. Epub 2009 Apr 11. — View Citation

Weiser SD, Tsai AC, Gupta R, Frongillo EA, Kawuma A, Senkungu J, Hunt PW, Emenyonu NI, Mattson JE, Martin JN, Bangsberg DR. Food insecurity is associated with morbidity and patterns of healthcare utilization among HIV-infected individuals in a resource-poor setting. AIDS. 2012 Jan 2;26(1):67-75. doi: 10.1097/QAD.0b013e32834cad37. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in economic status	Change in economic status between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention), as measured by a questionnaire containing questions on sources of livelihood (formal employment/wage labor, ganyu/casual labor, crop farming, livestock farming, trading/selling, etc.); exposure and coping methods to economic crises like major illness, environmental disasters, death of household member, etc.; housing quality like roof type (thatched roof, corrugated metal roof, tile, other), floor type (earth/mud, cement, tile, other), wall type (mud, brick, etc.); household assets like ownership of a hoe, axe, sickle, chemical sprayer, treadle pump, plough, etc. and livestock assets such as cattle, dairy cow, sheep, work oxen, etc.	Change in economic status between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention)	No
Primary	Change in food security	Change in food security between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on self-reported number of months in which a household did not have enough food to meet its family's needs; methods for coping with food shortages (such as engaging in ganyu/casual labor, selling firewood/charcoal, sell livestock, borrow cash/food, etc.); as well as quantitative anthropometric measurements of respondents and all household children under five years	Change in food security between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention)	No
Primary	Change in HIV vulnerability	Change in HIV vulnerability between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention)as measured by as measured by a questionnaire containing questions on self-reported HIV test results, status, and infection risk perceptions and behaviors	Change in HIV vulnerability between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in dietary diversity	Change in household dietary diversity between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on self-reported consumption of cereals, legumes, tubers, vitamin A-rich vegetables, vitamin A-rich fruits, meat, milk, fats, tea, etc.	Change in household dietary diversity between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in household perceptions of poverty	Change in household perceptions of poverty between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on respondents' self-categorization of their household wealth status; change in livelihood status across the past year; reasons for change in livelihood status	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)	No
Secondary	Change in household access to services	Change in household access to services between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on existing village institutions and receipt of services from different government ministries and NGO programs	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)	No
Secondary	Change in sustainable agriculture practices	Change in sustainable agricultural practices between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on the use of strategies for soil improvement, crop diversification, seed multiplication, drought-tolerant crops, intercropping, etc.	Change in sustainable agriculture practices between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in personal health	Change in personal health between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on the respondents' self-reported health status in general, in comparison to others in the village, health status compared to two years ago, physical limitations, frequency of experiencing pain in the past four weeks, etc.	Change in personal health between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in acute and chronic illness	6. Change in acute and chronic illness occurrence and healthcare seeking behavior between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on the household's recent need for treatment, where treatment was sought, etc.; and reports of disabled or chronically ill household members	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)	No
Secondary	Change in childbirth experiences	Change in childbirth experiences between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on the location of birth, major problems experienced by women giving birth (i.e. no transport to clinic, high cost, harsh treatment of staff at the health facility, etc.)	Change in childbirth experiences between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in family planning	Change in family planning between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on respondents' use (or non-use) and specific methods of family planning	Change in family planning between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in self-reported STD infections	Change in self-reported STD infections between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on respondents' experiencing of symptoms potentially indicative of a sexually transmitted infection, type of infection diagnosed, and treatment of such infections	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)	No
Secondary	Change in perceived HIV/AIDS stigma	Change in perceived HIV/AIDS stigma between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on respondents' likelihood of keeping a family members' status a secret	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)	No
Secondary	Change in self-reported male circumcision prevalence and attitudes	Change in self-reported male circumcision prevalence and attitudes between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions on respondents' knowledge of male circumcision and reported circumcision status	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)	No
Secondary	Change in gender power attitudes	Change in gender power attitudes between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions related to male partner treatment of female partners and intimate partner violence (i.e. does the male partner insist on knowing where you are at all times? Does the male partner push or shove you? Does the male partner hit you with his fist or with something else that could hurt you? Etc.)	Change in gender power attitudes between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No
Secondary	Change in community cohesion	Change in community cohesion between baseline (early stages of intervention), 18-month follow-up (end of intervention), and 36 month follow-up (post-intervention) as measured by a questionnaire containing questions related to scenarios in which the respondent would perceive a neighbor would contribute time or money to a community cause	Change in community cohesion between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)	No

External Links

•   Improved household resilience to economic shocks: findings from SAGE4Health, a mixed-methods, quasi-experimental, non-equivalent control group effectiveness study of a combined structural intervention in rural central Malawi
•   International Focus: The Economics of HIV/AIDS in Malawi. Milwaukee Public Television.