Getting to Zero: Safer Conception Programming to Eliminate Sexual and Perinatal HIV Transmission Among HIV Sero-different Couples in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of HIV infected men and their female partners attending Safer Conception Counselling Sessions and choosing a safer conception strategy that meets their needs
研究概览
简要总结
Despite effective strategies to reduce periconception HIV transmission, there are few services to support people living with or affected by HIV to use these methods. In particular, there is a lack of safer conception services focused on engaging men living with HIV. Given known gender inequities in childbearing decision-making and HIV risk, it is critical that safer conception services deliver programming that engages men living with HIV and their HIV sero-different partners. The Healthy Families program, based at the ISS Clinic at Mbarara Regional Referral Hospital, offers client-centered safer conception care to help HIV-affected individuals and couples meet reproductive goals. This care supports clients to leverage personal motivations and partner and social supports to overcome structural barriers and use Antiretroviral Therapy (ART), adopt other HIV-prevention strategies, and remain in care. This pilot study (the 'Getting to Zero' study) will assess uptake and experiences of safer conception care among 50 men living with HIV and their HIV sero-different partners. Investigators will also assess men's retention in HIV care and HIV transmission risk to partners and infants. This is a one-year mixed-methods prospective pilot research study, which will use electronic chart review data, longitudinal survey data (from the male index and female partner participant), and qualitative data from in-depth semi-structured interviews to meet study objectives. By demonstrating safer conception uptake and impact on HIV transmission risks to partners and infants, investigators aim to inform HIV and reproductive health policy in Uganda and globally.
详细描述
The Healthy Families safer conception program, based at the ISS Clinic at Mbarara Regional Referral Hospital (MRRH), offers client-centered care to help HIV-affected individuals and couples meet reproductive goals. This care supports clients to leverage personal motivations and partner and social supports to overcome structural barriers and use ART, adopt other HIV-prevention strategies, and remain in care. This pilot study (the 'Getting to Zero' study) will assess uptake and experiences of safer conception care among men living with HIV and their HIV sero-different partners, and will assess retention in care and HIV transmission risk to partners and infants.
There are six linked objectives in this study:
- To assess uptake of safer conception strategies among men living with HIV and/or their female partners overall, and by specific HIV prevention strategies.
Hypothesis 1: Investigators hypothesize that offering comprehensive safer conception services within HIV care will increase uptake of HIV prevention strategies among both male and female HIV-affected participants (including ART initiation, adherence, and HIV-RNA viral suppression in the partner living with HIV, HIV-serostatus disclosure, knowledge of partner's HIV-serostatus, Sexually Transmitted Infections (STI) testing and treatment, sexual behaviour (i.e., delaying condomless sex until HIV-infected partner is virally suppressed), and partner HIV testing and ARV use (PrEP or ART). 2. Among men living with HIV and their partners, to assess socio-demographic, relationship, structural, and clinical factors associated with uptake of safer conception strategies.
Hypothesis 2: Investigators hypothesize that uptake will be associated with more equitable relationship power and dynamics, lower HIV-related stigma, higher social support, and other socio-structural determinants of health. 3. To assess retention in HIV care among men living with HIV engaged in the safer conception intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •For enrollment in the Getting to Zero study, eligibility criteria for the index participant include the following:
- •Identify as male
- •HIV-positive
- •Report personal or partner desire to have a child in the next year
- •Identified pregnancy partner is reported to be HIV-negative or he doesn't know her HIV serostatus.
- •Aged 18 years or older.
- •Be naïve to the Healthy Families program.
- •Live within 60km of the ISS clinic and not planning to relocate to an area incompatible with an ability to attend the clinic over a 1 year follow-up period.
- •Able and willing to participate in the informed consent process.
- •Men living with HIV enrolled in the Getting to Zero study (index participants) will be asked for their consent to contact their partners to determine eligibility, interest, and willingness to participate in the Getting to Zero study. Partner participants must meet the following inclusion criteria:
- •Identify as a partner of an enrolled male Getting to Zero participant
- •Aged 18 years or older
- •Able and willing to participate in the informed consent process.
- •These participants will be referred to as the "partner". If the female partner is identified as HIV-positive after the male index participant enrolls in the Getting to Zero study, both partners remain eligible to participate.
- •Exclusion Criteria for Index Participant:
- •Identify as female
- •HIV-negative
- •Does not report personal or partner desire to have a child in the next year
- •Identified pregnancy partner is reported to be HIV-positive
- •Under age 18 years.
- •Be a patient of the Healthy Families program.
- •Live greater than 60km of the ISS clinic and planning to relocate to an area incompatible with attending the clinic over a 1 year follow-up period.
- •Unable and unwilling to participate in the informed consent process.
排除标准
- 未提供
结局指标
主要结局
Number of HIV infected men and their female partners attending Safer Conception Counselling Sessions and choosing a safer conception strategy that meets their needs
时间窗: 1.5 year
We will document the number of participants who return to their clinic with their female pregnancy partner to attend Safer Conception Counselling. We will also document the type of strategy chosen.
次要结局
- Number of men living with HIV retained in care who are part of the safer conception intervention.(1.5 year)
- Types of factors contributing to uptake of safer conception strategies among men living with HIV(1.5 year)
- Periconception HIV transmission incidence among HIV-affected individuals and couples.(1.5 year)
- HIV transmission incidence among HIV-affected individuals and couples where the male partner is living with HIV and engaged in the safer conception intervention.(1.5 year)
- HIV incidence among female partners of men living with HIV engaged in the safer conception intervention.(1.5 year)
研究者
Angela Kaida
Associate Professor
Simon Fraser University