Invitation Cards during Pregnancy Enhance Male Partner Involvement in Prevention of Mother to Child Transmission (PMTCT) of Human Immunodeficiency Virus (HIV) in Blantyre, Malawi: A Randomized Controlled Open Label Trial

<div><p>Introduction</p><p>Male involvement (MI) is vital for the uptake of Prevention of Mother to Child Transmission (PMTCT) of Human Immunodeficiency Virus (HIV) interventions. Partner notification (PN) is among the strategies identified for MI in PMTCT services. The purpose of this randomized controlled trial was to evaluate the efficacy of an invitation card to the male partners as a strategy for MI in PMTCT services by comparing the proportion of pregnant women that were accompanied by their partners between the intervention and the non-intervention study groups.</p><p>Methods</p><p>Pregnant women attending antenatal care without a male partner at South Lunzu and Mpemba health centres in Blantyre, Malawi, were enrolled in the study from June to December 2013. In an intention-to-treat analysis, we compared all participants that were randomized in the invitation card group with the standard of care (SoC) group. Risk ratios (RR) with 95% confidence intervals (CI) were computed to assess the efficacy of the invitation card.</p><p>Results</p><p>Of the 462 randomized women, 65/230 (28.26%) of the women in the invitation card group reported to the antenatal care clinic with their partners compared to 44/232 (18.97%) women in the SoC group. In an unadjusted intention-to-treat analysis women in the invitation card group were 50% more likely to be accompanied by their male partners than those in the SoC group RR: 1.49 (95% CI: 1.06-2.09); p = 0.02. Our random effects analysis showed that there was no clustering by site of recruitment with an inter cluster correlation coefficient (ICC) of 1.98x 10^-3, (95% CI: 1.78 x10^-7 - 0.96 x 10^-1); p =0.403.</p><p>Conclusion</p><p>An invitation card significantly increased the proportion of women who were accompanied by their male partners for the PMTCT services. An invitation card is a feasible strategy for MI in PMTCT.</p></div

Characteristics of Female participants (N = 462).

<p><i>* = only the highest proportions have been presented</i>, <i>therefore the figures are not adding up to N</i></p><p>Characteristics of Female participants (N = 462).</p

Characteristics of women whose partners reported versus women whose partners did not report to the Health Centres (N = 462).

<p><i>* = only the highest proportions have been presented</i>, <i>therefore the figures are not adding up to N</i></p><p>Characteristics of women whose partners reported versus women whose partners did not report to the Health Centres (N = 462).</p

MI in PMTCT study flow according to Consort Flow Diagram showing the participants flow and numbers at each stage in the study from screening, enrollment, allocation, follow up and analysis from June 2013 to February 2014.

<p>MI in PMTCT study flow according to Consort Flow Diagram showing the participants flow and numbers at each stage in the study from screening, enrollment, allocation, follow up and analysis from June 2013 to February 2014.</p

Unadjusted and Random Effects for the Primary outcome.

<p>RR: Risk Ratio</p><p>CI: Confidence Interval</p><p>ICC: Inter cluster correlation coefficient</p><p>Unadjusted and Random Effects for the Primary outcome.</p

Schematic of study design.

<p>Schematic of study design.</p

Preferences and acceptability of HIV testing and counseling options.

a<p>Question only asked to those who accepted self-testing (100 women and 97 men).</p><p>*<i>F</i>-test adjusted for the clustered design.</p><p>ND, not determined.</p

Help required and errors made by participants when self-testing.

<p>Help required and errors made by participants when self-testing.</p

Accuracy of self-test self-read results against gold standard.

<p>Parallel testing of finger-prick blood by a counselor using Determine and Unigold, Bioline if discordant.</p

Cross tabulation of OraQuick and confirmatory blood test results in all participants and participants not already known to be HIV positive.

<p>Participants with no confirmatory results are not included in sensitivity and specificity analyses. Inconclusive results are considered to be inaccurate (false) results in sensitivity and specificity analyses.</p