NCT00405990

Brief Summary

The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2008

Enrollment Period

1.1 years

First QC Date

November 30, 2006

Last Update Submit

May 28, 2015

Conditions

HIV Infections

Keywords

HIVMTCTheterosexual behavioursexual risk behaviourcouple counsellingVoluntary counselling and testingHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Percentage of partners agreeing to attend VCT.

    12 weeks

Secondary Outcomes (1)

  • Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.

    12 weeks

Interventions

Voluntary counselling and HIV testing in ANC for PMTCTBEHAVIORAL

VCT for 30 minutes in ANC

Also known as: ANC VCT, VCT for PMTCT
VCTBEHAVIORAL

HIV VCT for PMTCT

Also known as: VCT for PMTCT

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment.

You may not qualify if:

  • Women who are more than 30 weeks pregnant will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khayelitsha Midwive and Obstetric Unit Site B

Cape Town, Western Cape, 7784, South Africa

Location

Related Publications (1)

  • Mohlala BK, Boily MC, Gregson S. The forgotten half of the equation: randomized controlled trial of a male invitation to attend couple voluntary counselling and testing. AIDS. 2011 Jul 31;25(12):1535-41. doi: 10.1097/QAD.0b013e328348fb85.

    PMID: 21610487DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Boshishi K Mohlala, MBCHB FCOG MSC

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2007

Study Completion

May 1, 2008

Last Updated

May 29, 2015

Record last verified: 2008-05

Locations

ZA(1)