跳至主要内容
临床试验/NCT01693458
NCT01693458已完成3 期

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

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 1,046 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,046
试验地点
1
主要终点
HIV Testing or other related-services for network members of HIV Positive change agents.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Lifestyle counseling

Experimental

Appreciative Inquiry Change Agents (CA) Program (NAMWEZA)

干预措施: Appreciative Inquiry Change Agents (CA) program (NAMWEZA) (Behavioral)

Control group

Placebo Comparator

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

干预措施: Appreciative Inquiry Change Agents (CA) program (NAMWEZA) (Behavioral)

结局指标

主要结局

HIV Testing or other related-services for network members of HIV Positive change agents.

时间窗: 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.)

次要结局

  • Depressive symptoms(Baseline, 4 months, 8 months, 12 months, 16 months)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaie Fawzi

Professor

Harvard School of Public Health (HSPH)

研究点 (1)

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