Positive Change Agents Program-Tanzania (Evaluation)
Enabling People Living With HIV/AIDS (PHA) to Serve as Change Agents for HIV Prevention
1 other identifier
interventional
1,046
1 country
1
Brief Summary
The Appreciative Inquiry Change Agents (CA) program (NAMWEZA) intends to address broad societal issues by engaging HIV-positive leaders as 'change agents' in their communities. In this study, the CAs will be recruited from an HIV Care and Treatment Centre in Dar es Salaam. The Namweza program has the potential to address structural issues related to HIV risk, such as access to limited resources, through an entrepreneurial component of the program. A positive, or appreciative, focus promotes CAs to examine assets in themselves and in their networks, encourages strengthening of relationships, and facilitates planning for a positive future for themselves, their families, and their communities. A stepped wedge randomized trial will be performed to evaluate the effectiveness of the program for the following primary outcomes: uptake of HIV services among network members of the CAs; rate of unprotected sex and frequency of concurrent relationships among CAs and their social networks; and levels of self-esteem, general self efficacy, and risk of intimate partner violence in the CAs. Secondary outcomes include: depressive symptoms, hopefulness, and HIV-related stigma (among CAs); social support and quality of relationships (among CAs); and HIV knowledge, attitudes and self-efficacy in preventing HIV transmission or re-infection (CAs and their networks). The following are primary hypotheses that will be tested through this stepped wedge randomized trial evaluation:
- 1.Uptake of HIV services will increase among individuals in the network of the HIV-positive Change Agents related to the intervention;
- 2.Levels of self-esteem and general self-efficacy will increase in trained Change Agents;
- 3.Rate of unprotected sex and number of concurrent partners will decrease (among network of Change Agents as well as Change Agents themselves; i.e. the 'study population'); and
- 4.Prevalence of intimate partner violence (IPV) will decrease in Change Agents.
- 5.Prevalence of depressive symptoms and HIV-related stigma will decrease and level of hopefulness will increase in trained Change Agents;
- 6.Levels of HIV knowledge, attitudes and self-efficacy in preventing HIV transmission and re-infection among CA and their networks will increase; and
- 7.Degree of social support and quality of relationships will improve among CA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 20, 2015
October 1, 2015
2.8 years
July 5, 2012
October 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV Testing or other related-services for network members of HIV Positive change agents.
Change in HIV Testing status (for those with unknown HIV status) or access to HIV services (for those who are HIV-positive, e.g. viral load, antiretroviral therapy, etc.)
Baseline and every 4 months until end of study (4 times)
Secondary Outcomes (1)
Depressive symptoms
Baseline, 4 months, 8 months, 12 months, 16 months
Study Arms (2)
Lifestyle counseling
EXPERIMENTALAppreciative Inquiry Change Agents (CA) Program (NAMWEZA)
Control group
PLACEBO COMPARATORSince the design is a stepped-wedge randomized trial, those in the control group will eventually receive the intervention later in the study.
Interventions
The intervention is based on an Appreciative Inquiry approach that comprises a 10-session program based on learning by doing rather than factual classroom type learning, although it includes discussion of relevant facts about HIV, and other STIs. The intervention is based on the template of Stepping Stones (Jewkes et al., 2008), which is internationally one of the most widely used participatory behavioral interventions targeting sexual health. The Stepping Stones curriculum was shortened and radically adapted from more than 20 sessions. However NAMWEZA borrows generously from many of the exercises and games. It also employs the successful experience of stratification by age and sex to engage 4 different working groups (younger and older, male and female).
Eligibility Criteria
You may qualify if:
- HIV-positive, receiving HIV care at Sinza CTC and on ART for at least 3 months (transfer-in patients who are on ART will be considered eligible);
- lives in the catchment areas of the Kinondoni municipality and plans to remain in the area for at least two years;
- greater than or equal to 18 years of age;
- willingness to work with at least 20 members in their social network as a CA/educator in their community; and
- willingness to invite up to 10 social network members for involvement in the network members (NM) program.
- identified by CAs as at risk for HIV or intimate partner violence (IPV);
- lives in Dar es Salaam and plans to remain in area for at least 2 years; and
- greater than or equal to 18 years of age.
You may not qualify if:
- not well enough to attend training; or
- unable or unwilling to provide informed consent.
- enrolled as a CTC patient at Sinza Health Facility or
- enrolled as a NM for another CA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Dar es Salaam Region, 255, Tanzania
Related Publications (3)
Rewley J, Fawzi MCS, McAdam K, Kaaya S, Liu Y, Todd J, Andrew I, Onnela JP. Evaluating spillover of HIV knowledge from study participants to their network members in a stepped-wedge behavioural intervention in Tanzania. BMJ Open. 2020 Oct 7;10(10):e033759. doi: 10.1136/bmjopen-2019-033759.
PMID: 33033007DERIVEDSiril H, Smith Fawzi MC, Todd J, Somba M, Kaale A, Minja A, Killewo J, Mugusi F, Kaaya SF. The value of hope: development and validation of a contextual measure of hope among people living with HIV in urban Tanzania a mixed methods exploratory sequential study. BMC Psychol. 2020 Jan 29;8(1):5. doi: 10.1186/s40359-020-0376-y.
PMID: 31996246DERIVEDSmith Fawzi MC, Siril H, Liu Y, McAdam K, Ainebyona D, McAdam E, Somba M, Oljemark K, Mleli N, Lienert J, Andrew I, Haberlen S, Simwinga A, Todd J, Makongwa S, Li N, Kaaya S. Agents of change among people living with HIV and their social networks: stepped-wedge randomised controlled trial of the NAMWEZA intervention in Dar es Salaam, Tanzania. BMJ Glob Health. 2019 May 9;4(3):e000946. doi: 10.1136/bmjgh-2018-000946. eCollection 2019.
PMID: 31179027DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary C. Smith Fawzi, ScD
Harvard Medical School (HMS and HSDM)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 5, 2012
First Posted
September 26, 2012
Study Start
April 1, 2011
Primary Completion
January 1, 2014
Study Completion
September 1, 2014
Last Updated
October 20, 2015
Record last verified: 2015-10