Table 4.
Description of on-going trials
| Title | Status | Country | Subgroup | Intervention | Intervention allocation | Outcomes | Identifier |
|---|---|---|---|---|---|---|---|
| Linking Infectious and Narcology Care in Russia (LINC) [54] | Study start date: June 2012 Study completion date: April 2016 |
Russia | Injecting drug users, adults (18+), HIV infected | HIV case management delivered by a peer and point of care CD4 count testing | Individual randomized | Proportion of individuals initiating HIV care within 6 months of enrolment Proportion of individuals retained in HIV care 12 months after enrolment |
ClinicalTrials.gov: NCT01612455 |
| An intervention to improve antenatal access to CD4 testing an HAART Botswana [55] | Study start date: July 2011 Study completion date: October 2012 |
Botswana | Pregnant women, HIV infected | Improved access to CD4 phlebotomy, rapid CD4 result return via SMS messaging sub-Saharan Africa, active follow-up of treatment eligible women, participatory educational sessions for clinic staff, loan program for HIV and CD4 testing supplies | Step-wedge, cluster-randomized | Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation/prior to delivery Proportion of eligible women with HAART initiation prior to 30 weeks gestation/prior to delivery |
ClinicalTrials.gov: NCT01836003 |
| Home-based partner education and testing (HOPE) Study [56] | Study start date: May 2013 Study completion date: June 2014 |
Kenya | Pregnant women and their partners | Home-based partner education and HIV testing as part of routine pregnancy services | Individual randomized | Proportion of men linkage to HIV care 6 months post-partum (self-report) Proportion of men initiating ART 6 months post-partum (self-report) Proportion of women initiating ART 6 and 14 weeks post enrolment and 6 months postpartum (self-report) |
ClinicalTrials.gov: NCT01784783 |
| WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS [57] | Study start date: January 2013 Study completion date: March 2015 |
Kenya | Adults (18+), HIV infected | Weekly text-messages sub-Saharan Africa | Individual randomized | Proportion of individuals retained in care at 12 months Proportion of individuals completing 1st eligibility assessment within 3 months Proportion of individuals who complete 3 counselling sessions within 2 months |
ClinicalTrials.gov: NCT01630304 |
| Testing and linkage to care in injecting drug users in Kenya [58] | Study start date: March 2012 Study completion date: April 2015 |
Kenya | Injecting drug users, adults (18+) | POC CD4 count and peer care management | Individual randomized | Proportion of individuals linking to care (data collection done in 5 waves separated by 6 months) Time to ART |
ClinicalTrials.gov: NCT01557998 |
| Assisted partner notification to augment HIV treatment and prevention in Kenya (APS) [59] | Study start date: June 2012 Study completion date: May 2015 |
Kenya | Sexual partners of HIV-positive individuals | Assisted-partner notification | Individual randomized | Rate of linkage to HIV care of partners within 6 weeks of index case enrolment | ClinicalTrials.gov: NCT01616420 |
| Mobile phone technology for prevention of mother-to-child transmission of HIV: acceptability, effectiveness and cost [60] | Study start date: May 2011 Study completion date: April 2014 |
Kenya | Pregnant women, HIV infected | Mobile phone technology | Cluster randomized | Proportion of women who successfully complete key PMTCT transition points from antenatal care to 6 weeks postpartum Proportion of women on ART during labour, delivery and postpartum |
ClinicalTrials.gov: NCT01645865 |
| Integration of HIV care and treatment into antenatal care in Migori district, Kenya [61] | Study start date: June 2009 Study completion date: March 2012 |
Kenya | Pregnant women, HIV infected (18+) | Integrated ANC (health care providers within the ANC department will be trained to provide HIV/PMTCT care) | Cluster randomized | Proportion of women enrolled and retained in HIV care and treatment at 6 months and 1 year | ClinicalTrials.gov: NCT00931216 |
| Optimizing integrated PMTCT services in rural North-Central Nigeria [62] | Study start date: March 2013 Study completion date: September 2014 |
Nigeria | Pregnant women, HIV infected | Integrated PMTCT package: task-shifting to lower cadre, POC CD4 count testing, prominent role for male partners in collaborations with community health workers | Cluster randomized | Proportion of ART eligible pregnant women who initiated ART for the purposes of PMTCT | ClinicalTrials.gov: NCT01805752 |
| Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study) [63] | Study start date: October 2012 Study completion date: May 2015 |
South Africa | Non pregnant, adults (18+), HIV infected | ART initiation on the day of HIV testing | Individual randomized | Proportion of individuals alive, in care and virally suppressed at 6 months Average time to ART initiation |
ClinicalTrials.gov:NCT0171039 |
| Linkage and Retention: A Randomised Trial to Optimize HIV/TB Care in South Africa (Sizanani) [64] | Study start date: August 2010 Study completion date: January 2015 |
South Africa | Adults (18+), HIV infected | Patient navigator and short message service (SMS), sub-Saharan Africa, contacts throughout the follow-up period | Individual randomized | Proportion of ART eligible individuals linked and retained in ART care 9 months after enrolment | ClinicalTrials.gov: NCT01188941 |
| The “START” (a Streamlined ART Initiation Strategy) Study (START-ART) [65] | Study start date: April 2013 Study completion date: May 2016 |
Uganda | Adults (18+), HIV infected | POC CD4 testing, targeted knowledge transfer, feedback and reporting to clinic and providers | Randomized roll-out to clinics (step-wedge design) | Cumulative incidence of ART initiation in newly treatment eligible HIV-positive patients | ClinicalTrials.gov: NCT01810289 |
| The PeerCARE Study (Peer Community-based Assistant in Retention) [66] | Study start date: June 2011 Study completion date: June 2014 |
Uganda | Adults (18+), HIV infected | Peer health worker conducting home visit | Individual randomized | Time to ART initiation within 1 year | ClinicalTrials.gov: NCT01366690 |
| HIV counselling and testing and linkage to care in Uganda67 | Study start date: May 2008 Study completion date: August 2012 |
Uganda | Adult (18+) inpatients | More detailed counselling and enhanced linkage to care | Individual randomized(factorial design) | Proportion of individuals receiving of OI prophylaxis and adhering to ART Mortality |
ClinicalTrials.gov: NCT00648232 |
| Enhanced access to HIV care for drug users in San Juan, Puerto Rico [68] | Study start date: August 2013 Study completion date: April 2017 |
Puerto Rico | Injecting drug users (18+) | 1) neighbourhood-level HIV testing campaign 2) treatment re-engagement campaign using patient navigators for out of care HIV positive injecting drug users. 3) a patient navigator linkage to care and substance abuse treatment team 4) mobile HIV care clinic to facilitate linkage and retention |
Randomized roll-out design (similar to the stepped-wedge design) in 5 neighbourhoods | Proportion of individuals attending HIV care visit at 6 months intervals Proportion of individuals initiating ART at 6 months intervals |
ClinicalTrials.gov: NCT017927252 |
HAART=highly active antiretroviral therapy; SMS=short message service; ART=antiretroviral therapy; POC=point-of-care.