The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations
Abstract Background Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to f...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-11-01
|
| Series: | BMC Public Health |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12889-018-6120-3 |
| _version_ | 1819050544146153472 |
|---|---|
| author | Melissa Neuman Pitchaya Indravudh Richard Chilongosi Marc d’Elbée Nicola Desmond Katherine Fielding Bernadette Hensen Cheryl Johnson Phillip Mkandawire Alwyn Mwinga Mutinta Nalubamba Gertrude Ncube Lot Nyirenda Rose Nyrienda Eveline Otte im Kampe Miriam Taegtmeyer Fern Terris-Prestholt Helen A. Weiss Karin Hatzold Helen Ayles Elizabeth L. Corbett |
| author_facet | Melissa Neuman Pitchaya Indravudh Richard Chilongosi Marc d’Elbée Nicola Desmond Katherine Fielding Bernadette Hensen Cheryl Johnson Phillip Mkandawire Alwyn Mwinga Mutinta Nalubamba Gertrude Ncube Lot Nyirenda Rose Nyrienda Eveline Otte im Kampe Miriam Taegtmeyer Fern Terris-Prestholt Helen A. Weiss Karin Hatzold Helen Ayles Elizabeth L. Corbett |
| author_sort | Melissa Neuman |
| collection | DOAJ |
| description | Abstract Background Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. Methods Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. Discussion The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. Trial registration Clinicaltrials.gov, Malawi: NCT02718274, 18 March 2016; Zambia: NCT02793804, 3 June 2016. Protocol date: 21 February 2018. |
| first_indexed | 2024-12-21T11:49:44Z |
| format | Article |
| id | doaj.art-739887dbe8d54920a454aada8c018930 |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-12-21T11:49:44Z |
| publishDate | 2018-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-739887dbe8d54920a454aada8c0189302022-12-21T19:05:05ZengBMCBMC Public Health1471-24582018-11-0118111210.1186/s12889-018-6120-3The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluationsMelissa Neuman0Pitchaya Indravudh1Richard Chilongosi2Marc d’Elbée3Nicola Desmond4Katherine Fielding5Bernadette Hensen6Cheryl Johnson7Phillip Mkandawire8Alwyn Mwinga9Mutinta Nalubamba10Gertrude Ncube11Lot Nyirenda12Rose Nyrienda13Eveline Otte im Kampe14Miriam Taegtmeyer15Fern Terris-Prestholt16Helen A. Weiss17Karin Hatzold18Helen Ayles19Elizabeth L. Corbett20Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical MedicineMalawi-Liverpool-Wellcome Trust Clinical Research UnitPopulation Services InternationalFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineMalawi-Liverpool-Wellcome Trust Clinical Research UnitFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical MedicineFaculty of Infectious and Tropical Disease, London School of Hygiene and Tropical MedicineWorld Health OrganizationPopulation Services InternationalZambartSociety for Family HealthZimbabwe Ministry of HealthMalawi-Liverpool-Wellcome Trust Clinical Research UnitMalawi Ministry of HealthFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical MedicineLiverpool School of Tropical MedicineFaculty of Public Health and Policy, London School of Hygiene and Tropical MedicineFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical MedicinePopulation Services InternationalZambartMalawi-Liverpool-Wellcome Trust Clinical Research UnitAbstract Background Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. Methods Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. Discussion The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. Trial registration Clinicaltrials.gov, Malawi: NCT02718274, 18 March 2016; Zambia: NCT02793804, 3 June 2016. Protocol date: 21 February 2018.http://link.springer.com/article/10.1186/s12889-018-6120-3HIV/AIDSSelf-testingMalawiZambia |
| spellingShingle | Melissa Neuman Pitchaya Indravudh Richard Chilongosi Marc d’Elbée Nicola Desmond Katherine Fielding Bernadette Hensen Cheryl Johnson Phillip Mkandawire Alwyn Mwinga Mutinta Nalubamba Gertrude Ncube Lot Nyirenda Rose Nyrienda Eveline Otte im Kampe Miriam Taegtmeyer Fern Terris-Prestholt Helen A. Weiss Karin Hatzold Helen Ayles Elizabeth L. Corbett The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations BMC Public Health HIV/AIDS Self-testing Malawi Zambia |
| title | The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations |
| title_full | The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations |
| title_fullStr | The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations |
| title_full_unstemmed | The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations |
| title_short | The effectiveness and cost-effectiveness of community-based lay distribution of HIV self-tests in increasing uptake of HIV testing among adults in rural Malawi and rural and peri-urban Zambia: protocol for STAR (self-testing for Africa) cluster randomized evaluations |
| title_sort | effectiveness and cost effectiveness of community based lay distribution of hiv self tests in increasing uptake of hiv testing among adults in rural malawi and rural and peri urban zambia protocol for star self testing for africa cluster randomized evaluations |
| topic | HIV/AIDS Self-testing Malawi Zambia |
| url | http://link.springer.com/article/10.1186/s12889-018-6120-3 |
| work_keys_str_mv | AT melissaneuman theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT pitchayaindravudh theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT richardchilongosi theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT marcdelbee theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT nicoladesmond theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT katherinefielding theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT bernadettehensen theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT cheryljohnson theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT phillipmkandawire theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT alwynmwinga theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT mutintanalubamba theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT gertrudencube theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT lotnyirenda theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT rosenyrienda theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT evelineotteimkampe theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT miriamtaegtmeyer theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT fernterrisprestholt theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT helenaweiss theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT karinhatzold theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT helenayles theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT elizabethlcorbett theeffectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT melissaneuman effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT pitchayaindravudh effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT richardchilongosi effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT marcdelbee effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT nicoladesmond effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT katherinefielding effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT bernadettehensen effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT cheryljohnson effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT phillipmkandawire effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT alwynmwinga effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT mutintanalubamba effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT gertrudencube effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT lotnyirenda effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT rosenyrienda effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT evelineotteimkampe effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT miriamtaegtmeyer effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT fernterrisprestholt effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT helenaweiss effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT karinhatzold effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT helenayles effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations AT elizabethlcorbett effectivenessandcosteffectivenessofcommunitybasedlaydistributionofhivselftestsinincreasinguptakeofhivtestingamongadultsinruralmalawiandruralandperiurbanzambiaprotocolforstarselftestingforafricaclusterrandomizedevaluations |