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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02332265
• Date of registration: 21/12/2014
• Prospective Registration: No
• Primary sponsor: University of Wisconsin, Milwaukee
• Public title: Evaluation of the Effects of a Structural Economic and Food Security Intervention on HIV Vulnerability in Rural Malawi SAGE4Health
• Scientific title: Pathways Linking Poverty, Food Insecurity, and HIV in Rural Malawi
• Date of first enrolment: February 2009
• Target sample size: 1901
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02332265
• Study type: Observational
• Study design: N/A
• Phase: N/A

Countries of recruitment

Malawi

Contacts

• Name: Lance Weinhardt, PhD
• Affiliation: University of Wisconsin, Milwaukee, Zilber School of Public Health

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

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

Primary Outcome(s)

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 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 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)]

Secondary Outcome(s)

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 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 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)]

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 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 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 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 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 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 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 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 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 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)]

Secondary ID(s)

R01HD055868

144-PRJ51ZT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Malawi

CARE Malawi

University of Pennsylvania