CHARISMA Expansion Study
Condition: Relationship Dynamics; Pre-exposure Prophylaxis (PrEP) Adherence
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.

      This study will enroll sexually active, HIV-uninfected women, who are trial naïve,
      non-pregnant and aged 18-45 years (inclusive). PrEP, delivered according to national
      guidelines, IPV screening using the WHO Violence Against Women Survey (VAWS) and referrals
      for care will be offered to all eligible participants as Standard of Care (SOC) in the
      control arm. CHARISMA intervention arm participants will receive in-person counselling as
      part of the CHARISMA intervention to help them assess and build support for PrEP use within
      their relationships. SHs, IPV, relationship dynamics (e.g. communication, support) and PrEP
      adherence will be compared across the two arms. Social harms are defined as non-clinical
      trial related adverse events that result in psychosocial, social, or physical harm among
      women.

      Design: Two-arm, randomized (1:1), controlled study of a behavioral intervention to increase
      adherence to daily oral PrEP, improve partner relationships (communication and support) and
      reduce SH and IPV.

      A PrEP delivery project will be established in accordance with national guidelines in South
      African Department of Health (DoH) PrEP guidelines supplemented by the addition of the
      CHARISMA intervention. Participants presenting for enrolment will be randomized to one of two
      study arms below:

        1. Control: Standard of care (SOC) HIV prevention services in line with the South African
           DoH PrEP rollout program that include daily oral TDF/FTC. In addition, risk reduction
           counseling, IPV screening using the VAWS with referrals for counseling, medical care, or
           shelter assistance, among other care options if needed and an informational packet
           regarding HIV prevention services for themselves and male partners will be offered;

        2. CHARISMA Intervention: SOC per control arm plus provider-administration of HEART and
           provider-administration of CHARISMA counseling modules, as applicable:

             -  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

      Population: Approximately four hundred sexually active, HIV-uninfected women who are trial
      naïve, non-pregnant, and not planning to be pregnant for the next six months,
      non-breastfeeding, aged 18 to 45 years of age (inclusive)

      Study Site(s): Wits RHI (Reproductive Health and HIV Institute) Clinical Research Site,
      Johannesburg, South Africa Other site(s) to be determined

      Approach: This project will offer a PrEP delivery package within two arms of a controlled,
      randomized study of women to evaluate the impact of the CHARISMA intervention when paired
      with PrEP delivery.

      Study Duration: Accrual will require approximately 12 months. Each participant presenting for
      PrEP education and services will be enrolled and followed for 6 months. Participants in both
      study arms will participate in scheduled visits for screening, enrollment, and months 1, 3,
      and 6 of follow-up. A subset of participants will be asked to participate in a qualitative
      interview at month 6, and/or month 9.

      Primary Objectives:

        1. To determine the effectiveness of the CHARISMA intervention in increasing PrEP
           adherence/persistence at month 6;

        2. To determine the effectiveness of the CHARISMA intervention in reducing reported
           experiences of social harms while on PrEP;

        3. To determine the effectiveness of the CHARISMA intervention in reducing reported
           experiences of IPV (irrespective of time on PrEP);

        4. To determine the effectiveness of CHARISMA on participant's reported relationship
           dynamics, including disclosure of PrEP use, support for product use, and communication;

           Secondary Objective:

        5. To explore the acceptability and feasibility of the CHARISMA intervention; and

      Exploratory Objective:

      7) To assess the sensitivity and specificity of a brief IPV screening tool compared to a
      longer validated tool in identifying cases of IPV.
    

Intervention name(s): Control; CHARISMA Intervention
Intervention type(s): Other; Behavioral
Intervention description(s): Standard of care (SOC) HIV prevention services in line with the South African DoH (Department of Health) PrEP (Pre-exposure Prophylaxis) rollout program that include daily oral TDF/FTC (tenofovir disoproxil fumarate/emtricitabine). In addition, risk reduction counseling, IPV (Intimate Partner Violence) screening using the VAWS (WHO Violence Against Women Survey) with referrals for counseling, medical care, or shelter assistance, among other care options, if needed and an informational packet regarding HIV prevention services for themselves and male partners will be offered; SOC (Standard of Care) per control arm plus provider-administration of HEART and provider-administration of CHARISMA counseling modules, as applicable:
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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm, randomized (1:1), controlled study of a behavioral intervention to increase adherence to daily oral PrEP, improve partner relationships (communication and support) and reduce social harms and IPV.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP (Pre-exposure Prophylaxis); HIV prevention; Intimate Partner Violence (IPV)