Acute HIV InfectionPhase 3NCT01197027
Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection
A Phase 3 study testing Standard counseling in people with Acute HIV Infection, run by HIV Prevention Trials Network at 1 site in Malawi.
Trial summary
The purpose of this study is to evaluate the acceptability and feasibility of an enhanced, individual-level counseling intervention for individuals in the acute and early phase of HIV infection aimed at reducing risk behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute HIV Infection
- What is being tested?
- Standard counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMalawi
- Study dates
- Feb 2010to Apr 2012
- Phase
- Phase 3
- 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
- Be enrolled in CHAVI 001 Note: The inclusion and exclusion criteria for CHAVI 001 are provided below. The criteria will not be reassessed prior to enrollment in HPTN 062.
- Men and women aged ≥ 18 years at the time of screening.
- Able and willing to provide adequate information for locator purposes.
- Hemoglobin > 10.0 g/dL.
- Willing to receive HIV test results.
- Not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area.
- Has acute HIV infection. (See Section 2.3 for definition).
Who cannot join
- Any prior or current use of antiretroviral therapy (ART). This does not apply to individuals screening for Group 1A. ART use for the prevention of perinatal transmission may be waived after prior consultation with the protocol team.
- Previous or current participation in a HIV vaccine study. HPTN 062 Version 3.0 Final 03 August 2010
- Any condition that, in the opinion of the Investigator of Record, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the acceptability and feasibility of an enhanced, individual-level counseling intervention for individuals in the acute and early phase of HIV infection aimed at reducing risk behaviors.
- Conditions
- Acute HIV Infection
- Being tested
- Standard counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard counselingBehavioural
Standard HIV counseling
| Study group | Role | What they receive |
|---|---|---|
| Enhanced counseling | Experimental | 5 intensive counseling sessions following acute HIV infection Receives: Behavioral: Standard counseling |
| Standard counseling | Active comparator | Standard HIV counseling following acute HIV infection Receives: Behavioral: Standard counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit
Measured: Week 2
Secondary outcomes (1)
Number of self-reported unprotected sex acts
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 posted9 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionApr 2012
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 Acute HIV InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Amy Corneli, PhD, Study chair, FHI 360Audrey Pettifor, PhD, Study chair, FHI 360Francis Martinson, Md, PhD, Principal investigator, Kamuzu Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197027
- Sponsor's protocol ID
- HPTN 062
- Status last verified
- Aug 2022
- First submitted
- 7 Sep 2010
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Pettifor A, Corneli A, Kamanga G, McKenna K, Rosenberg NE, Yu X, Ou SS, Massa C, Wiyo P, Lynn D, Tharaldson J, Golin C, Hoffman I; HPTN 062 Study Protocol Team. HPTN 062: A Pilot Randomized Controlled Trial Exploring the Effect of a Motivational-Interviewing Intervention on Sexual Behavior among Individuals with Acute HIV Infection in Lilongwe, Malawi. PLoS One. 2015 May 11;10(5):e0124452. doi: 10.1371/journal.pone.0124452. eCollection 2015.
PubMed 25962118
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection
- ClinicalTrials.gov ID
- NCT01197027
- Acronym / sponsor ID
- HPTN 062
- Conditions
- Acute HIV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Sep 2010 (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 purpose of this study is to evaluate the acceptability and feasibility of an enhanced, individual-level counseling intervention for individuals in the acute and early phase of HIV infection aimed at reducing risk behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced counseling | Experimental | Behavioral: Standard counseling5 intensive counseling sessions following acute HIV infection |
| Standard counseling | Active comparator | Behavioral: Standard counselingStandard HIV counseling following acute HIV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be enrolled in CHAVI 001 Note: The inclusion and exclusion criteria for CHAVI 001 are provided below. The criteria will not be reassessed prior to enrollment in HPTN 062.
Key exclusion criteria (3 listed)
- Any prior or current use of antiretroviral therapy (ART). This does not apply to individuals screening for Group 1A. ART use for the prevention of perinatal transmission may be waived after prior consultation with the protocol team.
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 |
|---|---|---|
| Standard counselingStandard HIV counseling | Behavioural | Enhanced counseling, Standard counseling |
Primary outcome
Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit
Time frame: Week 2
1 secondary outcome
Number of self-reported unprotected sex acts
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 26 Aug 2022.
- Derived from this study: PubMed 25962118Pettifor A, Corneli A, Kamanga G, McKenna K, Rosenberg NE, Yu X, Ou SS, Massa C, Wiyo P, Lynn D, Tharaldson J, Golin C, Hoffman I; HPTN 062 Study Protocol Team. HPTN 062: A Pilot Randomized Controlled Trial Exploring the Effect of a Motivational-Interviewing Intervention on Sexual Behavior among Individuals with Acute HIV Infection in Lilongwe, Malawi. PLoS One. 2015 May 11;10(5):e0124452. doi: 10.1371/journal.pone.0124452. eCollection 2015.
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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.
Amy Corneli, PhD study chair
FHI 360
Audrey Pettifor, PhD study chair
FHI 360
Francis Martinson, Md, PhD principal investigator
Kamuzu Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard counseling in people with Acute HIV Infection, run by HIV Prevention Trials Network at 1 site in Malawi.
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 26 Aug 2022. 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 Malawi. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit (time frame: Week 2). 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 NCT01197027, 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 26 Aug 2022.