Positive Change Agents Program-Tanzania (Evaluation)
|ClinicalTrials.gov Identifier: NCT01693458|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : October 20, 2015
|First Submitted Date ICMJE||July 5, 2012|
|First Posted Date ICMJE||September 26, 2012|
|Last Update Posted Date||October 20, 2015|
|Start Date ICMJE||April 2011|
|Primary Completion Date||January 2014 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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) ]
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.)
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01693458 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Depressive symptoms [ Time Frame: Baseline, 4 months, 8 months, 12 months, 16 months ]
Change in level/severity of depressive symptoms over the course of the study.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Positive Change Agents Program-Tanzania (Evaluation)|
|Official Title ICMJE||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:
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||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
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2014|
|Primary Completion Date||January 2014 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Inclusion criteria for NMs will be as follows:
Exclusion Criteria for NMs will be as follows:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Tanzania|
|Removed Location Countries|
|NCT Number ICMJE||NCT01693458|
|Other Study ID Numbers ICMJE||TZ.08.0147|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Wafaie Fawzi, Harvard School of Public Health|
|Study Sponsor ICMJE||Harvard School of Public Health|
|PRS Account||Harvard School of Public Health|
|Verification Date||October 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP