Othman Kakaire1, Josaphat Kayogoza Byamugisha2, Nazarius Mbona Tumwesigye3, Kristina Gemzell-Danielsson4. 1. Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Mulago Hospital Complex, PO Box 7072, Old Mulago Hill, Kampala, Uganda kakaireothman@hotmail.com. 2. Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Mulago Hospital Complex, PO Box 7072, Old Mulago Hill, Kampala, Uganda. 3. School of Public Health, Makerere University College of Health Sciences, Mulago Hospital Complex, Old Mulago Hill, Kampala, Uganda. 4. Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Abstract
STUDY QUESTION: Does laboratory testing after syndromic screening for sexually transmitted infections (STIs) reduce the rate of intrauterine contraception (IUC) removal among women living with HIV/AIDS (WLHA)? SUMMARY ANSWER: Additional laboratory testing after syndromic screening for STIs did not affect the likelihood that a woman would remove an IUC immediately or within 1 year of IUC use or the frequency of post-insertion unscheduled clinic visits. In low-risk WLHA, the incidence rate of IUC removal is low with or without laboratory testing. WHAT IS KNOWN ALREADY: Fear of infectious morbidity remains an obstacle to uptake of IUC by WLHA. The value of laboratory testing after syndromic screening for STI before the insertion of IUC remains uncertain. STUDY DESIGN, SIZE, DURATION: We enrolled WLHA from 2 September to 6 December 2013 and followed them up to 31 December 2014. After syndromic screening, 703 women free of STIs were randomized to either additional laboratory screening or no additional screening for STI before IUC insertion. The randomization sequence was generated by an independent statistician and randomization numbers placed in opaque sequentially numbered sealed envelopes. All women randomized had an IUC inserted and in all 672 participants completed the 1-year follow-up. The study staff who followed up the participants were blinded to the study allocation groups. Incidence rate ratios (IRRs) were used to compare the incidence rates of IUC removal, unscheduled clinic attendance and IUC continuation between the two groups. PARTICIPANTS/MATERIALS, SETTING, METHODS:Women eligible to participate were 18-49 years old at study entry, in a relationship with a male partner, wanted to avoid pregnancy for at least 1 year and were undergoing HIV/AIDS care at Mulago Hospital, Uganda. Participants completed a baseline questionnaire and up to four follow-up questionnaires until discontinuation of IUC, loss to follow-up or end of study observation after 12 months. MAIN RESULTS AND THE ROLE OF CHANCE: The rate of IUC removal was 8.8% (29/331) in the no additional screening group and 8.0% (27/341) in the additional laboratory screening group [IRR 1.1 (95% CI 0.63-1.93)]. Unscheduled clinic attendances were similar in the two groups at 1 year of IUC insertion: 13.6% (45/331) in the no additional screening group and 12.3% (42/241) in the additional laboratory screening group. During the 1-year follow-up, only five women, three from the no additional screening group and two from the additional laboratory screening group, developed pelvic inflammatory disease (PID), as defined by established diagnostic criteria. LIMITATIONS, REASONS FOR CAUTION: We were not able to carry out STI risk assessment directly from the men thus women with high-risk partners could have been included in the study and this may be responsible for the lack of a demonstrable effect of additional laboratory screening on incidence rates of IUC removals and unscheduled clinic attendance. The diagnosis of PID was based on clinical signs and symptoms; therefore, subclinical PID could have been missed. WIDER IMPLICATIONS OF THE FINDINGS: Among WLHA, the incidence rate of IUC removal is low and IUC continuation high. Syndromic screening for STIs could be sufficient in indentifying WLHA who are suitable for IUC use. However, our findings are only generalizable to women in HIV/AIDS care who have access to good follow-up. STUDY FUNDING/COMPETING INTERESTS: The study was supported by Medical Education for Equitable Services to all Ugandans, a Medical Education Partnership Initiative grant number 5R24TW008886 from the office of Global AIDS Coordinator and the US Department of Health and Human Services, Health Resources and Services Administration and National Institutes of Health. Additional funding was from the Swedish International Development Agency, Swedish Research Council (SIDA/VR). The authors have no competing interests to declare. TRIAL REGISTRATION NUMBER: This trial was registered at Pan African Clinical Trial, Registry. PACTR 201308000561212.
RCT Entities:
STUDY QUESTION: Does laboratory testing after syndromic screening for sexually transmitted infections (STIs) reduce the rate of intrauterine contraception (IUC) removal among women living with HIV/AIDS (WLHA)? SUMMARY ANSWER: Additional laboratory testing after syndromic screening for STIs did not affect the likelihood that a woman would remove an IUC immediately or within 1 year of IUC use or the frequency of post-insertion unscheduled clinic visits. In low-risk WLHA, the incidence rate of IUC removal is low with or without laboratory testing. WHAT IS KNOWN ALREADY: Fear of infectious morbidity remains an obstacle to uptake of IUC by WLHA. The value of laboratory testing after syndromic screening for STI before the insertion of IUC remains uncertain. STUDY DESIGN, SIZE, DURATION: We enrolled WLHA from 2 September to 6 December 2013 and followed them up to 31 December 2014. After syndromic screening, 703 women free of STIs were randomized to either additional laboratory screening or no additional screening for STI before IUC insertion. The randomization sequence was generated by an independent statistician and randomization numbers placed in opaque sequentially numbered sealed envelopes. All women randomized had an IUC inserted and in all 672 participants completed the 1-year follow-up. The study staff who followed up the participants were blinded to the study allocation groups. Incidence rate ratios (IRRs) were used to compare the incidence rates of IUC removal, unscheduled clinic attendance and IUC continuation between the two groups. PARTICIPANTS/MATERIALS, SETTING, METHODS:Women eligible to participate were 18-49 years old at study entry, in a relationship with a male partner, wanted to avoid pregnancy for at least 1 year and were undergoing HIV/AIDS care at Mulago Hospital, Uganda. Participants completed a baseline questionnaire and up to four follow-up questionnaires until discontinuation of IUC, loss to follow-up or end of study observation after 12 months. MAIN RESULTS AND THE ROLE OF CHANCE: The rate of IUC removal was 8.8% (29/331) in the no additional screening group and 8.0% (27/341) in the additional laboratory screening group [IRR 1.1 (95% CI 0.63-1.93)]. Unscheduled clinic attendances were similar in the two groups at 1 year of IUC insertion: 13.6% (45/331) in the no additional screening group and 12.3% (42/241) in the additional laboratory screening group. During the 1-year follow-up, only five women, three from the no additional screening group and two from the additional laboratory screening group, developed pelvic inflammatory disease (PID), as defined by established diagnostic criteria. LIMITATIONS, REASONS FOR CAUTION: We were not able to carry out STI risk assessment directly from the men thus women with high-risk partners could have been included in the study and this may be responsible for the lack of a demonstrable effect of additional laboratory screening on incidence rates of IUC removals and unscheduled clinic attendance. The diagnosis of PID was based on clinical signs and symptoms; therefore, subclinical PID could have been missed. WIDER IMPLICATIONS OF THE FINDINGS: Among WLHA, the incidence rate of IUC removal is low and IUC continuation high. Syndromic screening for STIs could be sufficient in indentifying WLHA who are suitable for IUC use. However, our findings are only generalizable to women in HIV/AIDS care who have access to good follow-up. STUDY FUNDING/COMPETING INTERESTS: The study was supported by Medical Education for Equitable Services to all Ugandans, a Medical Education Partnership Initiative grant number 5R24TW008886 from the office of Global AIDS Coordinator and the US Department of Health and Human Services, Health Resources and Services Administration and National Institutes of Health. Additional funding was from the Swedish International Development Agency, Swedish Research Council (SIDA/VR). The authors have no competing interests to declare. TRIAL REGISTRATION NUMBER: This trial was registered at Pan African Clinical Trial, Registry. PACTR 201308000561212.
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