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

NCT02332265 | Completed

• 2 other identifiers: 144-PRJ51ZTR01HD055868
• Study Type: observational
• Target: 1,901
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Food Security; Microfinance; Village Savings and Loans; HIV; Quasi-experimental design; Malawi; Structural intervention

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Secondary Outcomes (13)

• Change in dietary diversity

  Change in household dietary diversity between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)

• 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), 36 month follow-up (post-intervention)

• 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), 36 month follow-up (post-intervention)

• Change in sustainable agriculture practices

  Change in sustainable agriculture practices between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)

• Change in personal health

  Change in personal health between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention)

Study Arms (3)

Program Participant Study SAFE area, control area

Participants from two types of areas of rural central Malawi: traditional authorities (TA) selected by CARE to receive the SAFE program (intervention group) and TAs receiving other unrelated CARE programming (controls). Intervention TAs: 598 program participants (398 women, 200 men) were interviewed at baseline and 18- and 36-month follow-ups; Control TAs: 301 control households were interviewed at baseline and 18- and 36-month follow-ups

Other: Support to Able-Bodied Vulnerable groups to Achieve Food Security (SAFE)

Community Impact Study, non-SAFE participants

We conducted random surveys (n = 1002)--501 living in the intervention areas but not directly receiving the SAFE intervention and 501 living in the control areas not receiving the SAFE intervention with a 36-month assessment interval, prior to and after implementation of SAFE. Thus, we examined intervention outcomes both in direct SAFE program participants and their larger communities. We used multilevel modeling to examine mediators and moderators of the effects of SAFE on HIV outcomes at the individual and community levels and determine the ways in which changes in HIV outcomes feed back into economic outcomes and food security at later interviews.

Qualitative SAFE program participant in-depth interview & FGD

We conducted a qualitative end-of-program evaluation consisting of in-depth interviews with 90 SAFE participants.

Other: Support to Able-Bodied Vulnerable groups to Achieve Food Security (SAFE)

Interventions

Support to Able-Bodied Vulnerable groups to Achieve Food Security (SAFE) OTHER

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/.

Program Participant Study SAFE area, control area; Qualitative SAFE program participant in-depth interview & FGD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \[Study 1: Prospective participant sample (intervention) and Study 3: End-of-program implementation qualitative sample\] (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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• CARE Malawi: collaborator
• University of Pennsylvania: collaborator
• University of Malawi: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

CARE International-Malawi

Lilongwe, Malawi

Location

Related Publications (16)

• 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.

  PMID: 21904186 BACKGROUND

• 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.

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  PMID: 19213758 BACKGROUND

• 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.

  PMID: 18687460 BACKGROUND

• Krieger N. Epidemiology and the web of causation: has anyone seen the spider? Soc Sci Med. 1994 Oct;39(7):887-903. doi: 10.1016/0277-9536(94)90202-x.

  PMID: 7992123 BACKGROUND

• 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.

  PMID: 20405316 BACKGROUND

• 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.

  PMID: 19926798 BACKGROUND

• 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. doi: 10.1016/S0140-6736(06)69744-4.

  PMID: 17141704 BACKGROUND

• Weinhardt LS, Galvao 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. No abstract available.

  PMID: 19363651 BACKGROUND

• Victora CG, Habicht JP, Bryce J. Evidence-based public health: moving beyond randomized trials. Am J Public Health. 2004 Mar;94(3):400-5. doi: 10.2105/ajph.94.3.400.

  PMID: 14998803 BACKGROUND

• Sumartojo E. Structural factors in HIV prevention: concepts, examples, and implications for research. AIDS. 2000 Jun;14 Suppl 1:S3-10. doi: 10.1097/00002030-200006001-00002.

  PMID: 10981469 BACKGROUND

• Sepulveda 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.

  PMID: 22778344 BACKGROUND

• 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.

  PMID: 18670227 BACKGROUND

• 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.

  PMID: 22313952 BACKGROUND

• 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.

  PMID: 19294500 BACKGROUND

• 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.

  PMID: 22989491 BACKGROUND

Related 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.

Study Officials

• Lance Weinhardt, PhD

  University of Wisconsin, Milwaukee, Zilber School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: January 6, 2015
• Study Start: February 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

MA (1)