Community Health Clinic Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) Expansion Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 2
- 主要终点
- Incidence of social harms (SHs) using a SHs questionnaire
研究概览
简要总结
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social harms (SHs) and intimate partner violence (IPV), increase healthy relationship dynamics and oral PrEP (pre-exposure prophylaxis) TDF/FTC (tenofovir disoproxil fumarate/emtricitabine), hereafter called PrEP, adherence among enrolled women. This study is an expansion of the CHARISMA intervention pilot study which was appended to the Microbicide Trials Network (MTN)-025 HOPE (HIV Open Label Prevention Extension) study.
CHARISMA is defined by the use of a tool, called the CHARISMA HEAlthy Relationship Assessment Tool (HEART) used in combination with three counselling modules:
- Module A: General Partner Communication and Relationship Skills
- Module B: Partner Disclosure and Communication around PrEP Use
- Module C: Responding to Intimate Partner Violence and Safety Planning
详细描述
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-which aims to reduce social harms (SHs) and intimate partner violence (IPV), increase healthy relationship dynamics and oral PrEP TDF/FTC (hereafter called PrEP) adherence among enrolled women. This study is an expansion of the CHARISMA intervention pilot study which was appended to the Microbicide Trials Network (MTN)-025 HOPE study and will conclude in 2018.
CHARISMA is defined by the use of a tool, called the CHARISMA HEAlthy Relationship Assessment Tool (HEART) used in combination with three counselling modules:
- Module A: General Partner Communication and Relationship Skills
- Module B: Partner Disclosure and Communication around PrEP Use
- Module C: Responding to Intimate Partner Violence and Safety Planning
The HEART will be used to assess the status of women's relationships and experience of IPV in the intervention arm. The HEART, previously piloted in HOPE, is a tool used to facilitate assessment of, and response to, the range of positive and negative effects of HIV prevention product use experienced by women in intimate partner relationships.
In September 2015, the World Health Organization issued guidelines recommending PrEP be offered to all persons at substantial HIV risk (defined as HIV incidence rate above 3%) worldwide. In sub-Saharan Africa, women account for 58% of the total number of people living with HIV. Given the high HIV incidence and evidence for high potential effectiveness of PrEP when adherence to product use is high, PrEP delivery, adherence, and associated male partner dynamics should be evaluated among a broad age range of 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
- •Able and willing to provide written informed consent and locator information
- •Reports having a current male primary partner,
- •Sexually active, defined by vaginal intercourse with a male at least 4 times per month in the past 3 months and plan to be sexually active during the study duration
- •Not pregnant (defined by urine pregnancy testing) and not breastfeeding
- •Not planning on becoming pregnant in the next 6 months
- •English or Zulu speaking
- •HIV negative based on negative HIV rapid tests, at the time of enrollment
排除标准
- •Previously participated in a clinical trial or a longitudinal HIV prevention research study
- •Unwilling to use daily oral PrEP
- •Has any significant medical condition or other condition that, in the opinion of the Principal Investigator (PI)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
结局指标
主要结局
Incidence of social harms (SHs) using a SHs questionnaire
时间窗: Anytime during the study, up to 6 months
SH in this study could include negative consequences related to study participation, PrEP use disclosure, stigma, gender-based violence, and relationship problems. Participants will be screened for SH resulting from product use or study participation at Enrollment, Month 3, and Month 6, and may report a social harm to staff at any time during the study.
Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire
时间窗: 6 months
Consistent with the primary objective to determine the effect of CHARISMA on participants' relationship dynamics, the following endpoints will be assessed: * Disclosure of PrEP use to male partners: Self-report that participants have told their partners that they are using PrEP * Male partner support for product use: Self-report that male partners support or accept (i.e. do not oppose) their PrEP use * Communication with male partners: Self-report of partnership communication dynamics All participants will be asked about relationship dynamics, including disclosure of PrEP use, support for product use, and communication during enrollment, month 3, and 6 follow-up visits, and as needed during month 1 visits.
IPV: Self-report of a) any IPV or b) physical or sexual IPV during study participation.
时间窗: Anytime during the study, up to 6 months
All participants will receive SOC IPV screening at enrollment and at the Month 3 and Month 6 visits and may report IPV to staff at any time during the study. SOC IPV screening will include clinical screening with a validated IPV measurement tool-the WHO VAWS. The WHO considers the VAWS to be a valid and reliable measure of GBV (gender-based violence) and is therefore a reasonable SOC screening tool for this study.
PrEP adherence/persistence by self-report
时间窗: 6 months
Self-reported data on PrEP adherence will be collected via standardized questionnaires to better understand patterns of PrEP use and reasons for poor adherence or discontinuation. The tool used for the assessment is the WHO VAWS. VAWS consists of behavior-specific items related to psychological (four items), physical (six items) and sexual violence (three items). The physical violence items are further divided into 'moderate' (the two first items) and 'severe' (the following four items) violence based on the likelihood of physical injury. Values are considered worse as responses to experiences of violence increase from no=0, to one=1, few=2, and many=3 times.
PrEP adherence/persistence by measurement
时间窗: 6 months
Adherence will be ascertained through measurement of TFV-DP in DBS specimens. DBS collected via blood draw at Month 3 and 6 follow-up visits will be used for retrospective PCR testing for tenofovir levels (although DBS is collected at Enrollment and Month 1 as well).
次要结局
- Acceptability and feasibility assessed by intervention tool utilization as reported in response to a questionnaire".-(6 months)
- Feasibility of the CHARISMA intervention - Measure of surveys and modules completed(Anytime during the study, up to 6 months)
- Feasibility of the CHARISMA intervention - Percentage of missing data(Anytime during the study, up to 6 months)
- Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.(9 months)
- Percentage of participants who complete the intervention as outlined by the protocol, assessed via case report forms(Anytime during the study, up to 6 months)
- Feasibility of the CHARISMA intervention - Time to completion(Anytime during the study, up to 6 months)
- Sensitivity and specificity of a brief intimate partner violence (IPV) screening tool compared to a longer validated tool in identifying cases of IPV.(3 months)
- Sensitivity and specificity of a brief IPV screening tool compared to a longer validated tool in identifying cases of IPV.(6 months)