HIV InfectionPhase 4NCT02775929

Partners Demonstration Project of PrEP and ART

A Phase 4 study testing FTC-TDF PrEP and ART in people with HIV Infection, run by University of Washington at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: FTC-TDF PrEP and ART
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,013 participants
Where: 4 sitesin 2 countries
Study dates: Nov 2012to Jun 2016
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For couples
Risk score defining higher HIV-1 risk (≥6)
Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
Did not participate in the Partners PrEP Study
For HIV-1 uninfected members of the couple (partner participants)

Show all 23Show fewer

Age ≥18
Able and willing to provide written informed consent
HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance >60 mL/min
Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
Not currently pregnant or breastfeeding
Not currently enrolled in an HIV-1 prevention clinical trial
Not currently using PrEP
Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator
For HIV-1 infected members of the couple (index participants)
Age ≥18
Able and willing to provide written informed consent
HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
No history of WHO stage III or IV conditions
Not currently using ART
Not currently enrolled in an HIV-1 treatment study
Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners

Who cannot join

Otherwise not eligible based on the above inclusion criteria

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Kenya2 sites

Kemri-Ucsf
Kisumu
Partners in Prevention-Thika
Thika

Other trials in Kenya

Uganda2 sites

Kabwohe Clinical Research Center
Bushenyi
Partners in Prevention-Infectious Diseases Institute LTD
Kampala

Other trials in Uganda

About this study

Official title: An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples

Read the detailed description

An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Conditions: HIV Infection
Being tested: FTC-TDF PrEP, ART
Keywords: Tenofovir disoproxil, Emtricitabine, Pre-exposure Prophylaxis, Antiretroviral Therapy, HIV Prevention, FTC TDF, PrEP, HIV Infected Partners, HIV Uninfected Partners
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FTC-TDF PrEPDrug
FTC-TDF PrEP for HIV-1 uninfected partners
ARTDrug
ART for HIV-1 infected partners

Study groups in NCT02775929
Study group	Role	What they receive
PrEP as a bridge to ART	Other	FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners Receives: Drug: FTC-TDF PrEP; Drug: ART

What is being measured

The primary outcome is the main question the study is designed to answer.

Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
High-risk couples defined by a validated risk scoring tool. Ability to recruit high-risk HIV-1 serodiscordant couples will be measured as screen-to-eligible ratio of HIV-1 serodiscordant couples.
Measured: 24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
High-risk couples defined by a validated risk scoring tool. We will measure the proportion of eligible couples who decide to enroll in the cohort.
Measured: 24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
High-risk couples were defined by a validated risk scoring tool. The cost-effectiveness analysis will follow World Health Organization (WHO) guidelines and report summary estimates for the PrEP intervention which allow comparison to other strategies to decrease HIV-1 transmission among serodiscordant couples. Costs of offering and delivering PrEP as a bridging strategy to ART, including recruitment costs for targeting higher-risk couples and PrEP delivery and monitoring costs will be collected. The incremental cost-effectiveness ratio (ICER) per HIV related infection, death and Disability-Adjusted Life Year (DALY) averted will be estimated. Results will be reported as the ICER of PrEP compared to current practice per incident HIV-1 case, HIV related death and DALY averted.
Measured: 24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
Measure the number of couples choosing to use PrEP or ART for HIV-1 prevention or both.
Measured: 24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods.
Quantitative questionnaire will be used to elicit reasons for the choice and concerns about both methods. Reasons for or concerns about both methods measured as proportion of participants reporting a particular reason for or concerns about both methods
Measured: 24 months
PrEP initiation by HIV uninfected partners.
Measure the number of HIV-1 uninfected partners initiating PrEP.
Proportion of samples with detectable and quantifiable PrEP levels
Measured: 24 months
PrEP adherence: Self-reported missed doses of PrEP.
Measure the proportion of visits when HIV-uninfected partner reported missing 1) any dose of PrEP in the prior quarter 2) 2 or more consecutive doses of PrEP.
Measured: 24 months
PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
Measure the proportion of plasma samples of HIV-1 uninfected partners with detectable and quantifiable PrEP levels.
Measured: 24 months
PrEP adherence: PrEP hold.
Measure the total number of HIV-1 uninfected partners with PrEP hold designated as a safety issue.
Measured: 24 months
ART initiation.
Measure the number of HIV-1 infected partners initiating ART.
Measured: 24 months
ART Adherence.
Measure the number of HIV-1 infected partners with suppressed plasma HIV-1 RNA levels.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
Proportion of visits when participants report having sex.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
Proportion of visits when participants report having condomless sex.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
Proportion of visits when HIV-1 uninfected partners report outside partners.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
Proportion of couples in which the HIV-1 uninfected partner is female.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
Proportion of couples with desire to conceive a child.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
Number of couples continuing their relationship during follow up.
Measured: 24 months
Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
Annual interviewer-administered questionnaire to collect depression and substance use indicators. Measure proportion of participants with depression and substance use.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
Proportion of HIV-1 infected partners initiating ART.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
Proportion of partnership reporting to have children at baseline.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
Proportion of HIV infected partners with CD4 count >200, >350, >500.
Measured: 24 months
Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
Proportion HIV-1 infected partners with WHO HIV-1 stage 1, 2, 3, or 4.
Measured: 24 months
Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
We will conduct in-depth interviews and focus group discussions. Qualitative analyses will identify and describe key themes and explore variation within themes of participants' attitudes and understanding of PrEP discontinuation.
Measured: 24 months
PrEP use and pregnancy: HIV-1 infection.
Number of HIV-1 infections among women who continue PrEP in pregnancy.
Measured: 24 months
PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
Infant outcomes measured as the number of live-born infants born to female participants taking PrEP that had any congenital anomalie.
Measured: 24 months
PrEP use and pregnancy: Any serious adverse event.
Number of women who continue PrEP in pregnancy with any serious adverse event.
Measured: 24 months
Infant growth for women who continue PrEP in pregnancy: Length.
Length of infants born to female Participants taking PrEP. The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
Measured: 24 months
Infant growth for women who continue PrEP in pregnancy: Weight.
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
Measured: 24 months
Infant growth for women who continue PrEP in pregnancy: Head circumference.
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant will be measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jun 2016

First posted18 May 2016 (estimated)
Study startNov 2012
Primary completionJun 2016
Study completionJun 2016

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 HIV InfectionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,013 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02775929
Sponsor's protocol ID: STUDY00001674
Other IDs: R01MH095507
Status last verified: Dec 2017
First submitted: 10 May 2016
Last updated: 8 Dec 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: Data from the Partners Demonstration Project are available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu).

Publications

Nakku-Joloba E, Pisarski EE, Wyatt MA, Muwonge TR, Asiimwe S, Celum CL, Baeten JM, Katabira ET, Ware NC. Beyond HIV prevention: everyday life priorities and demand for PrEP among Ugandan HIV serodiscordant couples. J Int AIDS Soc. 2019 Jan;22(1):e25225. doi: 10.1002/jia2.25225.
PubMed 30657642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples
ClinicalTrials.gov ID: NCT02775929
Acronym / sponsor ID: STUDY00001674
Conditions: HIV Infection
Keywords: Tenofovir disoproxil, Emtricitabine, Pre-exposure Prophylaxis, Antiretroviral Therapy, HIV Prevention, FTC TDF, PrEP, HIV Infected Partners
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,013 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation, National Institute of Mental Health (NIMH), United States Agency for International Development (USAID)
Study start: Nov 2012
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 18 May 2016 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PrEP as a bridge to ART	Other	Drug: FTC-TDF PrEP, Drug: ARTFTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

For couples
Risk score defining higher HIV-1 risk (≥6)
Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
Did not participate in the Partners PrEP Study

Key exclusion criteria (1 listed)

Otherwise not eligible based on the above inclusion criteria

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
FTC-TDF PrEPFTC-TDF PrEP for HIV-1 uninfected partners	Drug	PrEP as a bridge to ART
ARTART for HIV-1 infected partners	Drug	PrEP as a bridge to ART

Primary outcome

Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
Time frame: 24 months
High-risk couples defined by a validated risk scoring tool. Ability to recruit high-risk HIV-1 serodiscordant couples will be measured as screen-to-eligible ratio of HIV-1 serodiscordant couples.
Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
Time frame: 24 months
High-risk couples defined by a validated risk scoring tool. We will measure the proportion of eligible couples who decide to enroll in the cohort.
Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
Time frame: 24 months
High-risk couples were defined by a validated risk scoring tool. The cost-effectiveness analysis will follow World Health Organization (WHO) guidelines and report summary estimates for the PrEP intervention which allow comparison to other strategies to decrease HIV-1 transmission among serodiscordant couples. Costs of offering and delivering PrEP as a bridging strategy to ART, including recruitment costs for targeting higher-risk couples and PrEP delivery and monitoring costs will be collected. The incremental cost-effectiveness ratio (ICER) per HIV related infection, death and Disability-Adjusted Life Year (DALY) averted will be estimated. Results will be reported as the ICER of PrEP compared to current practice per incident HIV-1 case, HIV related death and DALY averted.
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
Time frame: 24 months
Measure the number of couples choosing to use PrEP or ART for HIV-1 prevention or both.
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods.
Time frame: 24 months
Quantitative questionnaire will be used to elicit reasons for the choice and concerns about both methods. Reasons for or concerns about both methods measured as proportion of participants reporting a particular reason for or concerns about both methods
PrEP initiation by HIV uninfected partners.
Time frame: 24 months
Measure the number of HIV-1 uninfected partners initiating PrEP. Proportion of samples with detectable and quantifiable PrEP levels
PrEP adherence: Self-reported missed doses of PrEP.
Time frame: 24 months
Measure the proportion of visits when HIV-uninfected partner reported missing 1) any dose of PrEP in the prior quarter 2) 2 or more consecutive doses of PrEP.
PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
Time frame: 24 months
Measure the proportion of plasma samples of HIV-1 uninfected partners with detectable and quantifiable PrEP levels.
PrEP adherence: PrEP hold.
Time frame: 24 months
Measure the total number of HIV-1 uninfected partners with PrEP hold designated as a safety issue.
ART initiation.
Time frame: 24 months
Measure the number of HIV-1 infected partners initiating ART.
ART Adherence.
Time frame: 24 months
Measure the number of HIV-1 infected partners with suppressed plasma HIV-1 RNA levels.
Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
Time frame: 24 months
Proportion of visits when participants report having sex.
Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
Time frame: 24 months
Proportion of visits when participants report having condomless sex.
Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
Time frame: 24 months
Proportion of visits when HIV-1 uninfected partners report outside partners.
Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
Time frame: 24 months
Proportion of couples in which the HIV-1 uninfected partner is female.
Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
Time frame: 24 months
Proportion of couples with desire to conceive a child.
Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
Time frame: 24 months
Number of couples continuing their relationship during follow up.
Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
Time frame: 24 months
Annual interviewer-administered questionnaire to collect depression and substance use indicators. Measure proportion of participants with depression and substance use.
Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
Time frame: 24 months
Proportion of HIV-1 infected partners initiating ART.
Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
Time frame: 24 months
Proportion of partnership reporting to have children at baseline.
Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
Time frame: 24 months
Proportion of HIV infected partners with CD4 count >200, >350, >500.
Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
Time frame: 24 months
Proportion HIV-1 infected partners with WHO HIV-1 stage 1, 2, 3, or 4.
Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
Time frame: 24 months
We will conduct in-depth interviews and focus group discussions. Qualitative analyses will identify and describe key themes and explore variation within themes of participants' attitudes and understanding of PrEP discontinuation.
PrEP use and pregnancy: HIV-1 infection.
Time frame: 24 months
Number of HIV-1 infections among women who continue PrEP in pregnancy.
PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
Time frame: 24 months
Infant outcomes measured as the number of live-born infants born to female participants taking PrEP that had any congenital anomalie.
PrEP use and pregnancy: Any serious adverse event.
Time frame: 24 months
Number of women who continue PrEP in pregnancy with any serious adverse event.
Infant growth for women who continue PrEP in pregnancy: Length.
Time frame: 24 months
Length of infants born to female Participants taking PrEP. The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
Infant growth for women who continue PrEP in pregnancy: Weight.
Time frame: 24 months
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
Infant growth for women who continue PrEP in pregnancy: Head circumference.
Time frame: 24 months
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant will be measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.

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 8 Dec 2017.
Derived from this study: PubMed 30657642Nakku-Joloba E, Pisarski EE, Wyatt MA, Muwonge TR, Asiimwe S, Celum CL, Baeten JM, Katabira ET, Ware NC. Beyond HIV prevention: everyday life priorities and demand for PrEP among Ugandan HIV serodiscordant couples. J Int AIDS Soc. 2019 Jan;22(1):e25225. doi: 10.1002/jia2.25225.
Individual participant dataSharing planned: Yes. Data from the Partners Demonstration Project are available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu).

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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.

Jared M Baeten, MD, PhD principal investigator

University of Washington

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FTC-TDF PrEP and ART in people with HIV Infection, run by University of Washington at 4 sites in 2 countries.

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 23 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Kenya, Uganda. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio. (time frame: 24 months). The study lists 29 primary outcomes in all. 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 NCT02775929, 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 8 Dec 2017.