Intimate Partner ViolenceNCT02577380
Addressing Gender Based Violence in HIV Testing and Counseling
A study testing IPV/GBV HTC in people with Intimate Partner Violence, run by Population Council.
Trial summary
The overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- IPV/GBV HTC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 2015
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Lived in the community for at least one year
- Aged 15-49 years
- Satisfy gender requirement
Who cannot join
- Lack of informed consent
About this study
The overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better address intimate partner violence in our work.
- Conditions
- Intimate Partner Violence
- Being tested
- IPV/GBV HTC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV/GBV HTCBehavioural
Participants will be interviewed after receiving their services.
| Study group | Role | What they receive |
|---|---|---|
| IPV/GBV HIV testing and counseling | Experimental | For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to IPV/GBV HTC HIV testing. Receives: Behavioral: IPV/GBV HTC |
| Standard HIV testing and counseling | No intervention | For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to Standard HIV testing and counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of HTC experiences
Number of ANC clients who meet an expected result of a survey with the intervention group (IPV/GBV-HTC) or with the control group (standard HTC). The score is based on answers given to attitudes toward study participant knowledge regarding IPV/GBV; awareness of IPV/GBV services; and agency regarding talking with their partner about HIV testing.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies 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
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Nicole Haberland, MPH, Principal investigator, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577380
- Sponsor's protocol ID
- Population Council # 640
- Status last verified
- Aug 2017
- First submitted
- 1 Oct 2015
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Haberland N, Ndwiga C, McCarthy K, Pulerwitz J, Kosgei R, Mak'anyengo M, Peltz A, Wong VJ, Kalibala S. Addressing Intimate Partner Violence and Power in Intimate Relationships in HIV Testing Services in Nairobi, Kenya. AIDS Behav. 2020 Aug;24(8):2409-2420. doi: 10.1007/s10461-020-02801-9.
PubMed 32026250
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Gender Based Violence in HIV Testing and Counseling
- ClinicalTrials.gov ID
- NCT02577380
- Acronym / sponsor ID
- Population Council # 640
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Oct 2015 (estimated)
- 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 overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better address intimate partner violence in our work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPV/GBV HIV testing and counseling | Experimental | Behavioral: IPV/GBV HTCFor the randomized controlled trial, first-time antenatal care clients will be randomly assigned to IPV/GBV HTC HIV testing. |
| Standard HIV testing and counseling | No intervention | –For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to Standard HIV testing and counseling. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Lived in the community for at least one year
- Aged 15-49 years
- Satisfy gender requirement
Key exclusion criteria (1 listed)
- Lack of informed consent
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 |
|---|---|---|
| IPV/GBV HTCParticipants will be interviewed after receiving their services. | Behavioural | IPV/GBV HIV testing and counseling |
Primary outcome
Comparison of HTC experiences
Time frame: 10 months
Number of ANC clients who meet an expected result of a survey with the intervention group (IPV/GBV-HTC) or with the control group (standard HTC). The score is based on answers given to attitudes toward study participant knowledge regarding IPV/GBV; awareness of IPV/GBV services; and agency regarding talking with their partner about HIV testing.
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 15 Aug 2017.
- Derived from this study: PubMed 32026250Haberland N, Ndwiga C, McCarthy K, Pulerwitz J, Kosgei R, Mak'anyengo M, Peltz A, Wong VJ, Kalibala S. Addressing Intimate Partner Violence and Power in Intimate Relationships in HIV Testing Services in Nairobi, Kenya. AIDS Behav. 2020 Aug;24(8):2409-2420. doi: 10.1007/s10461-020-02801-9.
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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.
Nicole Haberland, MPH principal investigator
Population Council
Questions about this trial
What is this clinical trial studying?
A study testing IPV/GBV HTC in people with Intimate Partner Violence, run by Population Council.
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 3 inclusion and 1 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 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of HTC experiences (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577380, which also lists 1 linked publication.
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 15 Aug 2017.