Positive Change Agents Program-Tanzania (Evaluation)

HIV Infection Clinical Trial

Official title:

Enabling People Living With HIV/AIDS (PHA) to Serve as Change Agents for HIV Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693458
• Other study ID #: TZ.08.0147
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2012
• Last updated: October 16, 2015
• Start date: April 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Description:

Intervention approach: Appreciative Inquiry Change Agents (CA) program (NAMWEZA) (see Appendix D for draft Facilitators' Guide). 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). The intervention is described in detail in Appendix D in the facilitators guide. A full draft curriculum is available on request. It is currently being translated into Swahili for use in Tanzania.

The intervention uses a number of psychological methods for creating change as effectively and rapidly as possible. It focuses on showing affirmation and being appreciative by looking for what is working in people's lives. Looking for resilience and coping strategies, and naming these, aims to raise self-esteem and the sense of competence in 'someone-who-has-a-future'. In every session, participants dream or imagine whom they might talk to about the things they have learned, or what they might do to prevent the spread of HIV personally or in their community. Imagining or dreaming their personal scenarios creates possibilities for different positive futures, for ways of behaving and being in relationship with people. These exercises, that are repeated every session in different forms, are designed to empower participants, giving them energy and hope. Participants learn and practice these life skills and report on their practical utility as they interact with their social networks each week.

Every exercise is discussed in small groups or role-played so that ideas and strategies can be shared and different responses can be practiced. Participants rehearse and try different ways of saying and doing things, until they find their own words and personal approaches within the given format. Discussions about love and safe, enjoyable sex allow participants to explore these personal subjects in the security of sex and age stratified groups. There is a particular emphasis on assertiveness and communication skills to raise self-esteem and decrease interpersonal violence.

Most sessions end with meditation or mindfulness so that people become aware of how their bodies feel. This helps them to recognize their own and others' body language and non-verbal communication, helping them to be more aware of other people's responses. Integration and awareness of the body is developed in the process of mindfulness training. This is particularly useful when thinking about disclosure and potential intimate partner violence (IPV).

Closing circle is a daily session closing/winding up activity where all participants gather into a circle and each has a chance to say one thing they have learned in that day which they might share with someone in the community and one thing they are looking forward to doing before the next meeting. As part of the intervention, facilitators will be required at the end of each session to document their perception of how the session was conducted and meet with other facilitators in a self evaluation and support session that will form the basis for preparation for the next training session. They will be requested to provide reports on level of participant's comfort with content of sessions, level of participation, range of learning reported, and areas for improvement reported.

The last sessions engage participants in thinking about practical issues of encouraging entrepreneurial skills. Participants explore ways that they might work in their local communities as change agents to reduce the spread of the virus and improve the situation of those living with HIV.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection

Intervention

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).

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar Es Salaam

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health	Centers for Disease Control and Prevention, Harvard Medical School, Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

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