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Positive Change Agents Program-Tanzania (Evaluation)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Appreciative Inquiry Change Agents (CA) program (NAMWEZA)
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV, prevention, HIV-positive, education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Muhimbili University of Health and Allied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lifestyle counseling

Control group

Arm Description

Appreciative Inquiry Change Agents (CA) Program (NAMWEZA)

Since the design is a stepped-wedge randomized trial, those in the control group will eventually receive the intervention later in the study.

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Depressive symptoms
Change in level/severity of depressive symptoms over the course of the study.

Full Information

First Posted
July 5, 2012
Last Updated
October 16, 2015
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Harvard Medical School (HMS and HSDM), Muhimbili University of Health and Allied Sciences, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01693458
Brief Title
Positive Change Agents Program-Tanzania (Evaluation)
Official Title
Enabling People Living With HIV/AIDS (PHA) to Serve as Change Agents for HIV Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Harvard Medical School (HMS and HSDM), Muhimbili University of Health and Allied Sciences, Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, prevention, HIV-positive, education

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1046 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Appreciative Inquiry Change Agents (CA) Program (NAMWEZA)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Since the design is a stepped-wedge randomized trial, those in the control group will eventually receive the intervention later in the study.
Intervention Type
Behavioral
Intervention Name(s)
Appreciative Inquiry Change Agents (CA) program (NAMWEZA)
Other Intervention Name(s)
Positive Change Agents Program- Tanzania
Intervention Description
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).
Primary Outcome Measure Information:
Title
HIV Testing or other related-services for network members of HIV Positive change agents.
Description
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.)
Time Frame
Baseline and every 4 months until end of study (4 times)
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Change in level/severity of depressive symptoms over the course of the study.
Time Frame
Baseline, 4 months, 8 months, 12 months, 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary C. Smith Fawzi, ScD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University of Health and Allied Sciences
City
Dar Es Salaam
ZIP/Postal Code
255
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
33033007
Citation
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.
Results Reference
derived
PubMed Identifier
31996246
Citation
Siril 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.
Results Reference
derived
PubMed Identifier
31179027
Citation
Smith 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.
Results Reference
derived

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Positive Change Agents Program-Tanzania (Evaluation)

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