Male Partner Involvement in the Prevention of MTCT of HIV | NCT00405990

Studies
Male Partner Involvement in the Prevention of MTCT of HIV

NCT00405990

Sponsor

Imperial College London

Status

Completed

Last Update Posted

May 29, 2015Estimated

Enrollment

1,000Estimated

Phase

Phase 4

Conditions

HIV Infections

Interventions

Voluntary counselling and HIV testing in ANC for PMTCT
VCT

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2007Actual

Completion Date

May 2008Actual

First Submitted Date

Nov 30, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2015

Last Update Posted Date

May 29, 2015Estimated

Name	Class
University of Cape Town	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

We will enrol 1000 pregnant women; recruited from antenatal clinic at Khayelitsha Midwive and Obstetric Unit (MOU). Community sensitization activities will be implemented in the catchment community to encourage male partner participation.

At the booking visit all women will be offered antenatal care, HIV group education and VCT as usual. Thereafter women will be recruited to enrol into the study, after signing the consent form half of the cohort members will be randomly assigned to partner VCT (Group A) and half to partner pregnancy information (Group B). Men in group B will be offered VCT at the second interview late in pregnancy. However, VCT will be provided if requested by study participants at any stage of the study or if the female partner is HIV positive. Women in group A will be given a written invitation to hand to their partners to encourage them to invite their partners to come to the antenatal clinic for VCT. In group B, women will be given a written invitation to give to their partners to encourage their partners to attend a pregnancy information session at the antenatal clinic.

VCT will be offered again close to delivery for all women and men who were previously uninfected or of unknown status. For those found to be HIV-infected at a prior visit, CD4 and CD8 T-cell counts, viral load, and full blood count tests will be conducted. Both women and men will be referred to the Antiretroviral clinic where ARV will be offered if appropriate and formula feeding (or exclusive breastfeeding) will be recommended. Reasons for declining VCT and data on sexual behaviour and violence will be sought at each visit.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voluntary counselling and HIV testing in ANC for PMTCT	Behavioral	VCT for 30 minutes in ANC		ANC VCT VCT for PMTCT
VCT	Behavioral	HIV VCT for PMTCT		VCT for PMTCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of partners agreeing to attend VCT.		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boshishi K Mohlala, MBCHB FCOG MSC	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khayelitsha Midwive and Obstetric Unit Site B		Cape Town	Western Cape	7784	South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21610487	Derived	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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

ID	Term
D008828	Microbiological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis