AzTrials
AzTrials

HIV InfectionPhase 3NCT01693458

Positive Change Agents Program-Tanzania (Evaluation)

A Phase 3 study testing Appreciative Inquiry Change Agents (CA) program (NAMWEZA) in people with HIV Infection, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
Appreciative Inquiry Change Agents (CA) program (NAMWEZA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,046 participants
Where
1 siteTanzania
Study dates
Apr 2011to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • not well enough to attend training; or
  • unable or unwilling to provide informed consent.
  • enrolled as a CTC patient at Sinza Health Facility or
  • enrolled as a NM for another CA

Trial locations and contacts

1 site in 1 country.

Tanzania1 site
  • Muhimbili University of Health and Allied Sciences

    Dar es Salaam, Dar es Salaam Region, 255

Other trials in Tanzania

About this study

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).

Read more

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.

Read the 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.

Conditions
HIV Infection
Being tested
Appreciative Inquiry Change Agents (CA) program (NAMWEZA)
Keywords
HIV, prevention, HIV-positive, education
Medical subject headings
HIV Infections, HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Appreciative Inquiry Change Agents (CA) program (NAMWEZA)Behavioural

    Also called Positive Change Agents Program- Tanzania

    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).

Study groups in NCT01693458
Study groupRoleWhat they receive
Lifestyle counselingExperimentalAppreciative Inquiry Change Agents (CA) Program (NAMWEZA)
Receives: Behavioral: Appreciative Inquiry Change Agents (CA) program (NAMWEZA)
Control groupPlacebo comparatorSince the design is a stepped-wedge randomized trial, those in the control group will eventually receive the intervention later in the study.
Receives: Behavioral: Appreciative Inquiry Change Agents (CA) program (NAMWEZA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: Baseline and every 4 months until end of study (4 times)

Secondary outcomes (1)
  1. Depressive symptoms

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

    Measured: Baseline, 4 months, 8 months, 12 months, 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2012 (estimated)
  2. Study startApr 2011
  3. Primary completionJan 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
1,046 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693458
Sponsor's protocol ID
TZ.08.0147
Status last verified
Oct 2015
First submitted
5 Jul 2012
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33033007
  • 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.

    PubMed 31996246
  • 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.

    PubMed 31179027

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Appreciative Inquiry Change Agents (CA) program (NAMWEZA) in people with HIV Infection, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01693458, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015; AzTrials last refreshed its copy on 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in