Comparison of Safety and Continuation of the Levonorgestrel Intrauterine System versus the Copper Intrauterine Device Among Women Living with HIV: A Randomised Controlled Trial

2019 ◽  
Author(s):  
Catherine Todd ◽  
Heidi E. Jones ◽  
Nontokozo Langwenya ◽  
Donald R. Hoover ◽  
Pai-Lien Chen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Women Living With Hiv ◽  
System Versus ◽  
Randomised Controlled ◽  
Living With Hiv ◽  
Copper Intrauterine Device

Immediate versus delayed insertion of the copper intrauterine device after medical abortion at 17–20 gestational weeks: a randomised controlled trial

2021 ◽  
pp. bmjsrh-2020-200932
Author(s):  
Deborah Constant ◽  
Margit Endler ◽  
Daniel Grossman ◽  
Gregory Petro ◽  
Malika Patel
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Medical Abortion ◽  
Tertiary Hospital ◽  
Community Healthcare ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
Post Abortion ◽  
Copper Intrauterine Device

IntroductionThis trial reports on use of the copper intrauterine device (IUD) after immediate compared with delayed insertion following medical abortion at 17–20 gestational weeks (GW).MethodsThis randomised controlled trial was conducted at one tertiary hospital and five community healthcare centres in Cape Town, South Africa. Eligible consenting women were randomised to immediate (within 24 hours) or delayed (3 weeks post-abortion) insertion of the copper IUD. Follow-up was at 6 weeks, 3 months and 6 months. Main outcomes were use of the original IUD and use of any IUD, including replacement IUDs at 6 weeks post-abortion. Secondary outcomes included rates of expulsion and malposition at 6 weeks, use of any IUD at 3 and 6 months, and acceptability of the IUD.ResultsWe recruited and randomised 114 women admitted for elective medical abortion between August 2018 and June 2019. In the immediate and delayed study arms, respectively, 45/55 (82%) and 12/57 (21%) women received the IUD as planned. By intention-to-treat, 56% in the immediate and 19% in the delayed arms were using the original IUD at 6 weeks (p<0.001), and 76% in the immediate and 40% in the delayed arms were using any IUD (p<0.001). Complete expulsion or removal occurred in 32% in the immediate and 7% in the delayed arms (p=0.044).ConclusionsInsertion of an IUD immediately after medical abortion at 17–20 GW results in increased use after 6 weeks compared with delayed insertion, however expulsion rates are higher than with interval insertion.Clinical trials registrationNCT03505047), Pan African Trials Registry (www.pactr.org), 201804003324963

scholarly journals Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

2017 ◽  
Vol 43 (3) ◽  
pp. 175-180 ◽  
Author(s):  
G Justus Hofmeyr ◽  
Mandisa Singata-Madliki ◽  
Theresa A Lawrie ◽  
Eduardo Bergel ◽  
Marleen Temmerman
Keyword(s):  
Randomised Controlled Trial ◽  
South African ◽  
Pregnancy Termination ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Randomised Trial ◽  
Contraceptive Device ◽  
Increased Risk ◽  
Hiv Acquisition ◽  
Randomised Controlled

BackgroundEvidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.MethodsWithin the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.ResultsHIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59;p=0.7).ConclusionsThis sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.Trial registration numberPan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

scholarly journals Agents of change among people living with HIV and their social networks: stepped-wedge randomised controlled trial of the NAMWEZA intervention in Dar es Salaam, Tanzania

2019 ◽  
Vol 4 (3) ◽  
pp. e000946 ◽  
Author(s):  
Mary C Smith Fawzi ◽  
Hellen Siril ◽  
Yuanyuan Liu ◽  
Keith McAdam ◽  
Donald Ainebyona ◽  
...  
Keyword(s):  
Social Networks ◽  
Randomised Controlled Trial ◽  
Hiv Risk ◽  
Controlled Trial ◽  
Risk Behaviour ◽  
Dar Es Salaam ◽  
People Living With Hiv ◽  
Stepped Wedge ◽  
Randomised Controlled ◽  
Living With Hiv

IntroductionNAMWEZA is a novel intervention that focuses on preventing HIV and promoting sexual and reproductive health and rights by addressing underlying factors related to vulnerability of acquiring HIV, such as depression, intimate partner violence (IPV) and stigma. The goal of the study was to evaluate the effect of the NAMWEZA intervention on risk behaviour as well as factors potentially contributing to this vulnerability for people living with HIV and their network members.MethodsA stepped-wedge randomised controlled trial was conducted from November 2010 to January 2014 among people living with HIV and their network members in Dar es Salaam, Tanzania. 458 people living with HIV were randomised within age/sex-specific strata to participate in the NAMWEZA intervention at three points in time. In addition, 602 members of their social networks completed the baseline interview. Intention-to-treat analysis was performed, including primary outcomes of uptake of HIV services, self-efficacy, self-esteem, HIV risk behaviour and IPV.ResultsFor people living with HIV, a number of outcomes improved with the NAMWEZA intervention, including higher self-efficacy and related factors, as well as lower levels of depression and stigma. IPV reduced by 40% among women. Although reductions in HIV risk behaviour were not observed, an increase in access to HIV treatment was reported for network members (72% vs 94%, p=0.002).ConclusionThese results demonstrate the complexity of behavioural interventions in reducing the vulnerability of acquiring HIV, since it is possible to observe a broad range of different outcomes. This study indicates the importance of formally evaluating interventions so that policymakers can build on evidence-based approaches to advance the effectiveness of HIV prevention interventions.Trial registration numberNCT01693458.

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