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Evaluation of the Effects of a Structural Economic and Food Security Intervention on HIV Vulnerability in Rural Malawi (SAGE4Health)

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ClinicalTrials.gov Identifier: NCT02332265
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Collaborators:
CARE Malawi
University of Pennsylvania
University of Malawi
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Lance Weinhardt, University of Wisconsin, Milwaukee

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.


Condition or disease Intervention/treatment
HIV Other: Support to Able-Bodied Vulnerable groups to Achieve Food Security (SAFE)

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1901 participants
Official Title: Pathways Linking Poverty, Food Insecurity, and HIV in Rural Malawi
Study Start Date : February 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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)
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/.

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)
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/.




Primary Outcome Measures :
  1. Change in economic status [ Time Frame: 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 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.

  2. Change in food security [ Time Frame: 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 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

  3. Change in HIV vulnerability [ Time Frame: Change in HIV vulnerability between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention) ]
    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


Secondary Outcome Measures :
  1. Change in dietary diversity [ Time Frame: 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 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.

  2. Change in household perceptions of poverty [ Time Frame: 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 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

  3. Change in household access to services [ Time Frame: 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 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

  4. Change in sustainable agriculture practices [ Time Frame: 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 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.

  5. Change in personal health [ Time Frame: Change in personal health between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention) ]
    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.

  6. Change in acute and chronic illness [ Time Frame: 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) ]
    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

  7. Change in childbirth experiences [ Time Frame: Change in childbirth experiences between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention) ]
    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.)

  8. Change in family planning [ Time Frame: Change in family planning between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention) ]
    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

  9. Change in self-reported STD infections [ Time Frame: 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) ]
    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

  10. Change in perceived HIV/AIDS stigma [ Time Frame: 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) ]
    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

  11. Change in self-reported male circumcision prevalence and attitudes [ Time Frame: 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) ]
    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

  12. Change in gender power attitudes [ Time Frame: Change in gender power attitudes between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention) ]
    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.)

  13. Change in community cohesion [ Time Frame: Change in community cohesion between baseline (early stages of intervention), 18-month follow-up (end of intervention), 36 month follow-up (post-intervention) ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332265


Locations
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Malawi
CARE International-Malawi
Lilongwe, Malawi
Sponsors and Collaborators
University of Wisconsin, Milwaukee
CARE Malawi
University of Pennsylvania
University of Malawi
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Lance Weinhardt, PhD University of Wisconsin, Milwaukee, Zilber School of Public Health

Additional Information:
Publications:

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Responsible Party: Lance Weinhardt, Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT02332265     History of Changes
Other Study ID Numbers: 144-PRJ51ZT
R01HD055868 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015
Keywords provided by Lance Weinhardt, University of Wisconsin, Milwaukee:
Food Security
Microfinance
Village Savings and Loans
HIV
Quasi-experimental design
Malawi
Structural intervention