HIV Infection Clinical Trial
Official title:
Enabling People Living With HIV/AIDS (PHA) to Serve as Change Agents for HIV Prevention
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.
Secondary hypotheses are:
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.
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.
Status | Completed |
Enrollment | 1046 |
Est. completion date | September 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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); 2. lives in the catchment areas of the Kinondoni municipality and plans to remain in the area for at least two years; 3. greater than or equal to 18 years of age; 4. able and willing to provide informed consent (Appendix B3) for inclusion in study; 5. willingness to work with at least 20 members in their social network as a CA/educator in their community; and 6. 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: 1. identified by CAs as at risk for HIV or intimate partner violence (IPV); 2. able and willing to provide informed consent (Appendix B4) for inclusion in study; 3. lives in Dar es Salaam and plans to remain in area for at least 2 years; and 4. greater than or equal to 18 years of age. Exclusion Criteria: 1. not well enough to attend training; or 2. unable or unwilling to provide informed consent. Exclusion Criteria for NMs will be as follows: 1. enrolled as a CTC patient at Sinza Health Facility or 2. enrolled as a NM for another CA |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Tanzania | Muhimbili University of Health and Allied Sciences | Dar Es Salaam |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health | Centers for Disease Control and Prevention, Harvard Medical School, Muhimbili University of Health and Allied Sciences |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Depressive symptoms | Change in level/severity of depressive symptoms over the course of the study. | Baseline, 4 months, 8 months, 12 months, 16 months | No |
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