Comparative Effectiveness of Individual Versus Group-level Interventions to Reduce HIV Risk Among African Immigrant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 424
- 试验地点
- 3
- 主要终点
- Proportion of participants who used condom during their last sexual intercourse
研究概览
简要总结
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women.
The specific aims of this study are:
- To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women
- To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women.
The adapted versions of these interventions will be given new names that resonate with the African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)" intervention while the adapted version of SISTA intervention will be called "DADA" intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western Africa.
详细描述
Background and Significance
African immigrants comprise a growing share of the US Black population, particularly in the Northeast. The population of African-born individuals in the US has doubled every decade since 1970; in 2015, there were 2.1 million African-born individuals in the US, more than 50% are female. Most are from Eastern (Ethiopia, Kenya and Somalia) and Western sub-Saharan Africa (Nigeria, Ghana and Liberia). Approximately one-third of the Black population within US cities are non-US born. One-third of new HIV diagnoses among African-born individuals occur in the Northeast, as opposed to the South where the majority of newly diagnosed US born Black individuals reside.
Among Black individuals in the US, African-born women have the highest rate of new HIV diagnoses due to heterosexual transmission. In 2014, the HIV diagnosis rate among African-born Black women was 400% higher than US born Black women. The rate of new HIV diagnoses among all Black women has decreased significantly, however the disparity between African-born and US born Black women increased. More than half of African-born Black individuals newly diagnosed with HIV are women (60.7%) compared to US born (27.0% women).
A significant proportion of HIV transmission cases among African-born women occurs post-immigration, here in the US. In a qualitative analysis conducted by our team in MA and NYC, 62% of HIV-infected African-born women believed that they contracted HIV in the US. Utilizing data on length of time in US, HIV testing, and life history, Wiewel et al concluded that 34% of HIV-infected African-born individuals were most likely infected in the US.
HIV risk among African-born Black women is due to complex cultural, psychosocial, and structural issues. PrEP is an effective HIV prevention strategy in women, and education about PrEP will be added to both interventions. Though African-born Black women are at-risk, there are no evidence-based interventions to address PrEP use, and little is known about its use among African-born women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV-negative
- •Born in an African country
- •Currently living in Greater Boston Area or New York City
- •Cis-gender woman
- •Self-reported Black or mixed-Black race
- •Fluent in English or French
- •Ages between 18 and 45
- •Report of condomless vaginal or anal sex with one or more male(s) in the last 3 months prior to enrollment
排除标准
- •Cis-gender man, transgender woman, transgender man, Pregnant woman
研究组 & 干预措施
Individual-level intervention
Virtual one-on-one session
干预措施: Dada Kwa Dada (individual-level) (Behavioral)
Group-level intervention
Virtual group sessions
干预措施: DADA (group-level) (Behavioral)
结局指标
主要结局
Proportion of participants who used condom during their last sexual intercourse
时间窗: 3-month and 6-months after intervention
Condom use at last sexual intercourse (Self-report yes/no) change from baseline to each followup)
Proportion of participants who obtained PrEP prescriptions.
时间窗: 3-months and 6-months after intervention
Participants who obtained prescription for PrEP (Self-report/medical record review)
Proportion of participants who are willing to take PrEP in the next 12 months.
时间窗: 3-months and 6-months after intervention
Participants who reported that they were extremely unlikely, very unlikely, somewhat unlikely, not sure, somewhat likely, very likely or extremely likely willing to take PrEP.
Proportion of participants who took PrEP through pill or injection.
时间窗: 3-months and 6-months after intervention
Participants who took daily PrEP pills or PrEP injection.
次要结局
- Proportion of participants with intention to get tested for HIV in the next 6 months.(6-months after intervention)
- Proportion of participants who tested positive for STI.(6-months after intervention)
- Proportion of participants who accepted HIV testing.(6-months after intervention)
研究者
Bisola O. Ojikutu, M.D.
Associate Professor of Medicine
Brigham and Women's Hospital