Positive Change Agents Program-Tanzania (Evaluation)
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Purpose
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:
- Uptake of HIV services will increase among individuals in the network of the HIV-positive Change Agents related to the intervention;
- Levels of self-esteem and general self-efficacy will increase in trained Change Agents;
- 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
Prevalence of intimate partner violence (IPV) will decrease in Change Agents.
Secondary hypotheses are:
- Prevalence of depressive symptoms and HIV-related stigma will decrease and level of hopefulness will increase in trained Change Agents;
- Levels of HIV knowledge, attitudes and self-efficacy in preventing HIV transmission and re-infection among CA and their networks will increase; and
- Degree of social support and quality of relationships will improve among CA.
If the proposed intervention is found to be effective, linkages with the Tanzanian Ministry of Health and other stakeholders will enable scale-up of the program throughout the country.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Behavioral: Appreciative Inquiry Change Agents (CA) program (NAMWEZA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Enabling People Living With HIV/AIDS (PHA) to Serve as Change Agents for HIV Prevention |
- HIV Testing or other related-services for network members of HIV Positive change agents. [ Time Frame: Baseline and every 4 months until end of study (4 times) ] [ Designated as safety issue: No ]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.)
- Depressive symptoms [ Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months ] [ Designated as safety issue: No ]Change in level/severity of depressive symptoms over the course of the study.
| Estimated Enrollment: | 1296 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lifestyle counseling
Appreciative Inquiry Change Agents (CA) Program (NAMWEZA)
|
Behavioral: Appreciative Inquiry Change Agents (CA) program (NAMWEZA)
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).
Other Name: Positive Change Agents Program- Tanzania
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|
Placebo Comparator: Control group
Since the design is a stepped-wedge randomized trial, those in the control group will eventually receive the intervention later in the study.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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;
- able and willing to provide informed consent (Appendix B3) for inclusion in study;
- 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.
Inclusion criteria for NMs will be as follows:
- identified by CAs as at risk for HIV or intimate partner violence (IPV);
- able and willing to provide informed consent (Appendix B4) for inclusion in study;
- 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.
Exclusion Criteria:
- not well enough to attend training; or
- unable or unwilling to provide informed consent.
Exclusion Criteria for NMs will be as follows:
- enrolled as a CTC patient at Sinza Health Facility or
- enrolled as a NM for another CA
Contacts and Locations| Tanzania | |
| Muhimbili University of Health and Allied Sciences | |
| Dar Es Salaam, Tanzania, 255 | |
| Principal Investigator: | Mary C. Smith Fawzi, ScD | Harvard Medical School |
More Information
No publications provided
| Responsible Party: | Wafaie Fawzi, Professor, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01693458 History of Changes |
| Other Study ID Numbers: | TZ.08.0147 |
| Study First Received: | July 5, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Tanzania: National Institute for Medical Research |
Keywords provided by Harvard School of Public Health:
|
HIV prevention HIV-positive education |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013