Relationship DynamicsCHARISMANCT04092114
CHARISMA Expansion Study
A study testing CHARISMA Intervention in people with Relationship Dynamics and Pre-exposure Prophylaxis (PrEP) Adherence, run by RTI International at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relationship Dynamics, Pre-exposure Prophylaxis (PrEP) Adherence
- What is being tested?
- CHARISMA Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Oct 2018to 25 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg, 2001
About this study
Official title: Community Health Clinic Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) Expansion Study
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
Read the 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:
- 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;
- 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:
- To determine the effectiveness of the CHARISMA intervention in increasing PrEP adherence/persistence at month 6;
- To determine the effectiveness of the CHARISMA intervention in reducing reported experiences of social harms while on PrEP;
- To determine the effectiveness of the CHARISMA intervention in reducing reported experiences of IPV (irrespective of time on PrEP);
- 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:
- To explore the acceptability and feasibility of the CHARISMA intervention; and
Exploratory Objective:
- To assess the sensitivity and specificity of a brief IPV screening tool compared to a longer validated tool in identifying cases of IPV.
- Being tested
- Control, CHARISMA Intervention
- Keywords
- PrEP (Pre-exposure Prophylaxis), HIV prevention, Intimate Partner Violence (IPV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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
CHARISMA InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Receives Standard of Care (SOC) services established in accordance with the South African Department of Health (DoH) PrEP (Pre-exposure Prophylaxis) guidelines. Receives: 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 Receives: Behavioral: CHARISMA Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (9)
Acceptability and feasibility assessed by intervention tool utilization as reported in response to a questionnaire".-
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Acceptability: Participant ranking of intervention components
Measured: 6 months
Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Acceptability: Participant qualitative report via interview
Measured: 6 months
Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Acceptability: Participant qualitative report via interview
Measured: 9 months
Feasibility of the CHARISMA intervention - Time to completion
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Feasibility: Process indicator of time to completion.
Measured: 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
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Feasibility: Process indicator of intervention fidelity
Measured: Anytime during the study, up to 6 months
Feasibility of the CHARISMA intervention - Measure of surveys and modules completed
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Feasibility: Process indicator of percentage of surveys and modules completed
Measured: Anytime during the study, up to 6 months
Feasibility of the CHARISMA intervention - Percentage of missing data
Consistent with the secondary objective to explore the acceptability and feasibility of CHARISMA, the following endpoint will be assessed:
- Feasibility: Process indicator of percentage of missing HEART data.
Measured: 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.
All participants will receive IPV screening at enrollment and at the Month 3 and Month 6 visits. 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 and is therefore a reasonable SOC screening tool for this study.
Measured: 3 months
Sensitivity and specificity of a brief IPV screening tool compared to a longer validated tool in identifying cases of IPV.
All participants will receive IPV screening at enrollment and at the Month 3 and Month 6 visits. 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 and is therefore a reasonable SOC screening tool for this study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start15 Oct 2018
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship DynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Wits Reproductive Health and HIV Institute, FHI 360, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Montgomery, PhD, MHS, Principal investigator, RTI InternationalThesla Palanee, MMedSci,PhD,MSc, Principal investigator, Wits RHI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092114
- Sponsor's protocol ID
- AID-OAA-A-15-00032
- Acronym
- CHARISMA
- Status last verified
- Jan 2023
- First submitted
- 28 May 2019
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Clinic Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) Expansion Study
- ClinicalTrials.gov ID
- NCT04092114
- Acronym / sponsor ID
- CHARISMA / AID-OAA-A-15-00032
- Keywords
- PrEP (Pre-exposure Prophylaxis), HIV prevention, Intimate Partner Violence (IPV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Wits Reproductive Health and HIV Institute, FHI 360, United States Agency for International Development (USAID)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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:
- To determine the effectiveness of the CHARISMA intervention in increasing PrEP adherence/persistence at month 6;
- To determine the effectiveness of the CHARISMA intervention in reducing reported experiences of social harms while on PrEP;
- To determine the effectiveness of the CHARISMA intervention in reducing reported experiences of IPV (irrespective of time on PrEP);
- 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:
- To explore the acceptability and feasibility of the CHARISMA intervention; and
Exploratory Objective:
- To assess the sensitivity and specificity of a brief IPV screening tool compared to a longer validated tool in identifying cases of IPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlReceives Standard of Care (SOC) services established in accordance with the South African Department of Health (DoH) PrEP (Pre-exposure Prophylaxis) guidelines. |
| CHARISMA Intervention | Experimental | Behavioral: CHARISMA InterventionReceives 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlStandard 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 | Other | Control |
| CHARISMA InterventionSOC (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 | Behavioural | CHARISMA Intervention |
Primary outcome
PrEP adherence/persistence by measurement
Time frame: 3 months
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).
PrEP adherence/persistence by measurement
Time frame: 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).
PrEP adherence/persistence by self-report
Time frame: 3 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 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.
PrEP adherence/persistence by self-report
Time frame: 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.
Incidence of social harms (SHs) using a SHs questionnaire
Time frame: 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.
IPV: Self-report of a) any IPV or b) physical or sexual IPV during study participation.
Time frame: 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.
Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire
Time frame: Enrollment
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.
Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire
Time frame: 1 month
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.
Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire
Time frame: 3 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.
Percent of participants who disclosed PrEP product use to a partner, which is reported via a questionnaire
Time frame: 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.
9 secondary outcomes
Acceptability and feasibility assessed by intervention tool utilization as reported in response to a questionnaire".-
Time frame: 6 months
Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.
Time frame: 6 months
Acceptability and feasibility assessed by participants' accounts of utilizing the CHARISMA intervention, as reported during an interview.
Time frame: 9 months
Feasibility of the CHARISMA intervention - Time to completion
Time frame: 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
Time frame: Anytime during the study, up to 6 months
Feasibility of the CHARISMA intervention - Measure of surveys and modules completed
Time frame: Anytime during the study, up to 6 months
Feasibility of the CHARISMA intervention - Percentage of missing data
Time frame: 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.
Time frame: 3 months
Sensitivity and specificity of a brief IPV screening tool compared to a longer validated tool in identifying cases of IPV.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Montgomery, PhD, MHS principal investigator
RTI International
Thesla Palanee, MMedSci,PhD,MSc principal investigator
Wits RHI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHARISMA Intervention in people with Relationship Dynamics and Pre-exposure Prophylaxis (PrEP) Adherence, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP adherence/persistence by measurement (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023; AzTrials last refreshed its copy on 26 Oct 2026.