Condition category
Infections and Infestations
Date applied
30/03/2016
Date assigned
31/03/2016
Last edited
23/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The human immunodeficiency virus (HIV) is a type of virus known as a retrovirus. HIV attacks and weakens the immune system, making it more difficult for a sufferer to fight infections. It is a highly contagious disease, through bodily fluids such as blood, semen and vaginal fluids. It is particularly common in sub-Saharan Africa and it is especially important that people in these regions are tested for HIV in order to minimise the spread of the disease. Wide roll out of availability of HIV tests has led to increases in numbers of people getting tested and starting on antiretroviral treatment (ART) in sub-Saharan Africa. Despite such remarkable progress, men continue to lag behind in HIV testing, including men in well-established relationships where HIV transmission is still surprisingly high. It is therefore important to investigate techniques to increase the number of men who are tested and can be linked into care (if they have HIV) or HIV prevention for men. The aim of this study is to compare the effectiveness of a range of interventions (programs) to encourage men in relationships to get tested for HIV and to link to a care or prevention service.

Who can participate?
All women attending their first antenatal clinic of a participating health clinic and their male partners.

What does the study involve?
36 clinic days across the three participating clinics are randomly allocated to one of seven groups. After agreeing to take part in the study, women complete a 10 minute interview with a research assistant about the woman's and her partner’s personal information and HIV testing. For those attending clinic days in the first group, they are given a personalised invitation letter to give to her partner so that he can use the letter to come to the trial “male friendly clinic” alone or together with her. Those attending clinic days in the second group receive the letter and at least two self-test kits to give to their partners. Those in the third group receive the letter, self-test kits and a $3 incentive when they link into male friendly clinic. Those in the fourth group receive the letter, self-test kits and a $10 incentive when they link into male friendly clinic. Those in the fifth group receive the letter, self-test kits and are entered into a lottery with a 10% chance of winning $30 when they link into male friendly clinic. Those in the sixth group receive the letter, self-test kits and are followed up with a phone call to remind them to use the rests and link into male friendly clinic. Those in the final group receive two self-test kits to deliver to their male partner, a as a phone call reminder the next day and five days later. When the women in all groups return for their next appointment four weeks later, they are interviewed to find out whether they faced any problems and whether or not her partner tested and linked to the “male friendly clinic”.

What are the possible benefits and risks of participating?
Male participants who attend the “male friendly clinic” will benefit from receiving care or prevention services. There are no direct risks to participating in the study except that some participants may be uncomfortable with some of the questions that will be asked.

Where is the study run from?
Three primary health clinics in urban Blantyre (Malawi)

When is the study starting and how long is it expected to run for?
March 2016 to June 2017

Who is funding the study?
Wellcome Trust (UK) (Grant number: 105828/Z/14/Z)

Who is the main contact?
Mr Augustine Choko
achoko@mlw.mw

Trial website

Contact information

Type

Public

Primary contact

Mr Augustine Choko

ORCID ID

http://orcid.org/0000-0001-6095-9430

Contact details

Malawi Liverpool Wellcome Trust Clinical Research Programme
P.O Box 30096
Chichiri
BT3
Blantyre
265
Malawi
+60 265 999 577 452
achoko@mlw.mw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: an adaptive Phase II multi-arm multi-stage cluster randomised trial

Acronym

Partner-provided self-testing and linkage (PASTAL)

Study hypothesis

What are the most promising candidate interventions for increasing uptake of HIV testing and linkage into care or prevention for partners of pregnant women attending antenatal clinics?

Ethics approval

London School of Hygiene & Tropical Medicine Ethics Committee, 10/06/2016

Study design

A Phase II adaptive multi-arm multi-stage cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

HIV

Intervention

36 clinic days will be randomised in blocks of different sizes to any of the six trial arms in stage 1 of the trial. All three clinic days available in one day will be per-identified before the randomisation such that the arm recruiting at a particular clinic on particular day will be known within the randomisation sequence.

Control arm: Women receive a letter addressed to their male partners.

Intervention arm 1: Women receive a letter and self-test kits to deliver to their male partners.

Intervention arm 2: Women receive a letter and self-test kits to deliver to their male partners who will get an incentive of $3 when they link into male friendly clinic and receive HIV care or HIV prevention services.

Intervention arm 3: Women receive a letter and self-test kits to deliver to their male partners who will get an incentive of $10 when they link into male friendly clinic and receive HIV care or HIV prevention services.

Intervention arm 4: Women receive a letter and self-test kits to deliver to their male partners who will be entered into a lottery with a 10% chance of winning $30 when they link into male friendly clinic and receive HIV care or HIV prevention services.

Intervention arm 5: Women receive a letter and self-test kits to deliver to their male partners who will receive a phone call to remind them to test and link into male friendly clinic to receive HIV care or HIV prevention services.

Intervention arm 6: Women receive two self-test kits to deliver to their male partner. A phone call reminder to self-test and link into care or prevention will be made to the male partner next day and after 5 days.

Participants in all groups are interviewed at their next appointment to determine the amount of male partners who used the self-test its and went to the male friendly clinic.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of male partners who test for HIV and link into care or prevention within 28 days is determined by the male partner undergoing HIV testing and receiving HIV care or prevention.

Secondary outcome measures

1. Proportion of women who participate in their allocated study arm is determined by face-to-face questionnaire at baseline.
2. Proportion of male partners who test for HIV within 28 days is determined by the male partner undergoing HIV testing
3. Cumulative incidence of intimate partner violence associated with each study arm is determined by audio computer assisted self-interview with women at 28 days
4. Total cost of implementing the service per study arm is determined by a costing questionnaire

Overall trial start date

01/03/2016

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

All women attending antenatal clinic for the first time at Ndirande PHC in urban Blantyre and their male partners.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

120 women and 120 men per arm in stage 1. Numbers for stage 2 will be determined at interim analysis.

Participant exclusion criteria

1. Have had couple or partner testing in this pregnancy
2. Under 18 years of age
3. The man is already aware of their HIV positive status and receiving treatment
4. Subsequent ANC visit
5. Already recruited in this trial
6. Not urban Blantyre resident

Recruitment start date

01/06/2016

Recruitment end date

01/01/2017

Locations

Countries of recruitment

Malawi

Trial participating centre

Ndirande Primary Health Centre
Ndirande
Blantyre
265
Malawi

Trial participating centre

Zingwangwa Primary Health Centre
Soche East
Blantyre
265
Malawi

Trial participating centre

Bangwe Health Primary Centre
Limbe
265
Malawi

Sponsor information

Organisation

London School of Hygiene & Tropical Medicine

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
+44 20 7636 8636
patricia.henley@lshtm.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results will be disseminated to HIV Unit in Malawi Ministry of Health, College of Medicine in Blantyre, and through conference presentations and publication in a peer-reviewed journal.

Intention to publish date

30/06/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/06/2016: The study sponsor has been changed from the Wellcome Trust to the London School of Hygiene & Tropical Medicine. In addition, a sixth intervention arm has been added to the interventions section of the study. ed ethics approval (UK, approval from Malawi still pending).