CHARISMA Expansion Study

NCT04092114 | Completed

• 1 other identifier: AID-OAA-A-15-00032
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Relationship Dynamics; Pre-exposure Prophylaxis (PrEP) Adherence

Keywords

PrEP (Pre-exposure Prophylaxis); HIV prevention; Intimate Partner Violence (IPV)

Outcome Measures

Primary Outcomes (10)

• PrEP adherence/persistence by measurement

  Adherence will be ascertained through measurement of TFV-DP (tenofovir-diphosphate) in dried blood spot (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).

  3 months

• PrEP adherence/persistence by measurement

  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).

  6 months

• PrEP adherence/persistence by self-report

  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 Violence Against Women Survey (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.

  3 months

• PrEP adherence/persistence by self-report

  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.

  6 months

• Incidence of social harms (SHs) using a SHs questionnaire

  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.

  Anytime during the study, up to 6 months

• IPV: Self-report of a) any IPV or b) physical or sexual IPV during study participation.

  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.

  Anytime during the study, up to 6 months

• Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire

  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.

  Enrollment

• Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire

  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.

  1 month

• Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire

  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.

  3 months

• Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire

  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.

  6 months

Secondary Outcomes (9)

• Acceptability and feasibility assessed by intervention tool utilization as reported in response to a questionnaire".-

  6 months

• Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.

  6 months

• Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.

  9 months

• Feasibility of the CHARISMA intervention - Time to completion

  Anytime during the study, up to 6 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

Study Arms (2)

Control

OTHER

Receives Standard of Care (SOC) services established in accordance with the South African Department of Health (DoH) PrEP (Pre-exposure Prophylaxis) guidelines.

Other: Control

CHARISMA Intervention

EXPERIMENTAL

Receives SOC (Standard of care) per control arm plus provider-administration of HEART (HEAlthy Relationship Assessment Tool) and provider-administration of CHARISMA (the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence) 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

Behavioral: CHARISMA Intervention

Interventions

Control OTHER

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

Control

CHARISMA Intervention BEHAVIORAL

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

CHARISMA Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RTI International: lead
• Wits Reproductive Health and HIV Institute: collaborator
• FHI 360: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg, 2001, South Africa

Location

Study Officials

• Elizabeth Montgomery, PhD, MHS

  RTI International

  PRINCIPAL INVESTIGATOR

• Thesla Palanee, MMedSci,PhD,MSc

  Wits RHI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: September 17, 2019
• Study Start: October 15, 2018
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)