Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial

<div><p>Objective</p><p>To evaluate feasibility of self-assessment of medical abortion outcome using a low-sensitivity urine pregnancy test, checklist and text messages. The study assessed whether accurate self-assessment required a demonstration of the low-sensitivity urine pregnancy test or if verbal instructions suffice.</p><p>Methods</p><p>This non-inferiority trial enrolled 525 adult women from six public sector abortion clinics. Eligible women were undergoing medical abortion at gestations within 63 days. Consenting women completed a baseline interview, received standard care with mifepristone and home-administration of misoprostol. All were given a low-sensitivity urine pregnancy test and checklist for use 14 days later, sent text reminders, and asked to attend in-clinic follow-up after two weeks. Women were randomly assigned 1:1 to an <i>instruction-only group</i> (n = 262; issued with pre-scripted instructions on the low-sensitivity pregnancy test), or a <i>demonstration group</i> (n = 263; performed practice tests guided by lay health workers). The primary outcome was accurate self-assessment of incomplete abortion, defined as needing additional misoprostol or vacuum aspiration. Analysis was by intention to treat and a non-inferiority margin was set to six percentage points. Women’s acceptability of their abortion procedure and preferences for follow-up were also assessed.</p><p>Results</p><p>Follow-up was 81% for abortion outcome, confirmed in-clinic at two weeks or self-reported within six months. Non-inferiority of instruction-only to a demonstration was inconclusive for accurate self-assessment (risk difference for <i>instruction-only –demonstration</i>: -2.5%; 95%CI: -9% to 4%). Comparing instruction-only to demonstration groups, 99% and 100% found the pregnancy test easy to do; and 91% and 93% respectively chose the pregnancy test, checklist and text messages for abortion outcome assessment in the future.</p><p>Conclusion</p><p>Routine self-assessment using a low-sensitivity pregnancy test, checklist and text messages is feasible and preferred by women attending South African primary care abortion clinics. Counselling with additional emphasis on prompt recognition of ongoing pregnancies is recommended.</p><p>Trial registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT02231619" target="_blank">NCT02231619</a></p></div

Trial profile.

<p>(A)Women returned to the clinic, but the provider was not present. In final FU phone contact abortion outcome was self-reported. (B)Women returned to the clinic, but the provider was not present. Final FU phone contact was unsuccessful and abortion outcome could not be confirmed. (C)Women did not return to the clinic, FU at 14 days was by phone. Final FU phone contact was unsuccessful and abortion outcome could not be confirmed.</p

Participant characteristics at enrollment by randomization group.

<p>Participant characteristics at enrollment by randomization group.</p

Observed difference (95% CI) between study groups for accurate self-assessment.

<p>Observed difference (95% CI) between study groups for accurate self-assessment.</p

Additional file 2: of Women’s experiences seeking informal sector abortion services in Cape Town, South Africa: a descriptive study

Survey Instrument. This is the survey instrument used to survey participants. (PDF 450 kb

Selected model input parameters for the base-case analysis (See S1 Table for complete list and ranges evaluated in sensitivity analyses).

<p><b>SD</b>: Standard deviation; <b>ART</b>: antiretroviral therapy; <b>PMTCT</b>: prevention of mother-to-child HIV transmission; <b>AZT</b>: azidothymidine (zidovudine); <b>ARV</b>: antiretroviral; <b>NVP</b>: nevirapine; <b>ABC</b>: abacavir; <b>3TC</b>: lamivudine; <b>LPV/r</b>: lopinavir/ritonavir; <b>TDF</b>: tenofovir; <b>FTC</b>: emtricitabine; <b>EFV</b>: efavirenz; <b>WHO</b>: World Health Organization</p><p><b>a</b>. Sensitivity and specificity were modeled with regard to true CD4 value of ≤350/μL (sensitivity: assay reports CD4 ≤350/μL when true CD4 is ≤350/μL; specificity: assay reports CD4 >350/μL when true CD4 is >350/μL). To be conservative with regard to the benefit of POC, we assumed in the base case that <i>laboratory</i> CD4 had 100% sensitivity and specificity to detect true CD4 ≤350/μL.</p><p><b>b</b>. In the base-case analysis, 13 weeks of antentatal AZT for non-ART eligible women are assumed in both strategies, based on median gestational age at booking in South Africa of 26 weeks. For ART-eligible women, 13 weeks of ART are assumed in the <i>POC</i> strategy and 3 weeks of AZT and 10 weeks of ART are assumed in the <i>laboratory</i> strategy.</p><p><b>c</b>. Please see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0117751#pone.0117751.s004" target="_blank">S1 Table</a> for description of assumptions of outpatient healthcare resource utilization.</p><p>Selected model input parameters for the base-case analysis (See <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0117751#pone.0117751.s004" target="_blank">S1 Table</a> for complete list and ranges evaluated in sensitivity analyses).</p

Multivariate sensitivity analyses: Cost-effectiveness of POC CD4 testing compared to laboratory testing.

<p>The cost-effectiveness of <i>POC</i> CD4 testing compared to <i>laboratory</i> testing is shown for key combinations of <i>POC</i> CD4 assay cost, <i>POC</i> assay sensitivity, and <i>POC</i> CD4 test and result return rates, defined as the product of (proportion of HIV-identified women undergoing CD4 testing) * (proportion of CD4-tested women receiving CD4 results). <b>Abbreviations</b>: POC: point-of-care testing.</p

Univariate sensitivity analyses: Pediatric life expectancy.

<p>Undiscounted pediatric life expectancies for <i>laboratory</i> and <i>POC</i> testing are shown (maternal life expectancies do not differ substantially by testing strategy, and so are excluded from the figure). <i>POC</i> “test and result return” is defined as the product of (proportion of HIV-identified women undergoing CD4 testing) * (proportion of CD4-tested women receiving CD4 results). For <i>POC</i> sensitivity and <i>POC</i> “test and result return,” life expectancies are shown at the threshold values at which <i>POC</i> testing no longer results in a higher life expectancy compared to <i>laboratory</i> testing. For <i>POC</i> specificity, life expectancy increases as specificity decreases, so no such threshold exists; results are shown at 50%, 80%, and 100%, as examples. The horizontal dotted line shows the undiscounted pediatric life expectancy under the base case laboratory conditions. Left panel: base case; middle panel: low laboratory access scenario; right panel: sensitivity analyses on <i>POC</i> parameters. <b>Abbreviations</b>: <i>POC</i>: point-of-care testing.</p

Budget impact analysis.

<p>Antenatal and pediatric care costs are shown for the first five years after birth. We include the <i>POC</i> and <i>laboratory</i> base case strategies, as well as the low laboratory access scenario. The arrows indicate the time points at which the upfront higher costs of <i>POC</i> testing are recovered due to savings in pediatric care costs. The open arrow indicates that <i>POC</i> becomes cost-saving compared to “low-access” <i>laboratory</i> testing within six months of delivery; the closed arrow indicates that <i>POC</i> becomes cost-saving compared to the base-case <i>laboratory</i> testing strategy within 36 months after delivery. Costs over the first five years after birth are further detailed in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0117751#pone.0117751.s007" target="_blank">S4 Table</a>. Maternal costs were nearly equivalent for both strategies, and are not shown. The sharp inflection point in costs at 6 months after delivery represents the cessation of breastfeeding the associated costs for infant nevirapine for postnatal MTCT prophylaxis. <b>Abbreviations</b>: POC: point-of-care testing; ANC: antenatal.</p

Model structure.

<p>This figure shows the modeled sequence of events during antenatal care that determine a mother’s prescribed PMTCT drug regimen. During the first visit, all women receive an HIV test and HIV test results. In the current analysis, all women who are HIV-infected are assumed to have positive HIV test results and enter the MTCT model, at which point they are assigned a probability of undergoing a CD4 test and, if tested, a probability of receiving their CD4 test results. Women are also modeled to be eligible for ART (true CD4 ≤350/μL) or non-eligible for ART (true CD4 >350/μL) based on 2010 WHO guidelines. The sensitivity and specificity of the CD4 assays are reflected in assigned probabilities that the CD4 test will indicate women to be eligible or non-eligible for ART. The observed CD4 results then determine whether women receive AZT or ART for PMTCT. Transmission probabilities and maternal outcomes depend on true CD4 count and PMTCT regimen received. <b>Abbreviations: ANC</b>: antenatal care; <b>POC</b>: point-of-care testing; <b>ART</b>: three-drug antiretroviral therapy; <b>AZT</b>: zidovudine.</p