A trial investigating multiple potential interventions for increasing uptake of HIV testing and linkage into care for male partners of pregnant women attending antenatal clinic through HIV self-testing

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18421340

Enrollment

240

Registered

2016-03-31

Start date

2016-06-01

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections and Infestations HIV

Interventions

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 random

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Malawi

Contacts

Public ContactAugustine Choko

achoko@mlw.mw+60 (0)265 999 577 452

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026