Trial record 3 of 38 for:    " June 20, 2012":" July 20, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Positive Change Agents Program-Tanzania (Evaluation)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Harvard Medical School
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01693458
First received: July 5, 2012
Last updated: October 9, 2013
Last verified: October 2013
  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:

  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.


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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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.)


Secondary Outcome Measures:
  • 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: March 2014
Estimated Primary Completion Date: December 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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693458

Locations
Tanzania
Muhimbili University of Health and Allied Sciences
Dar Es Salaam, Tanzania, 255
Sponsors and Collaborators
Harvard School of Public Health
Harvard Medical School
Muhimbili University of Health and Allied Sciences
Investigators
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: October 9, 2013
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 August 21, 2014